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Trial record 66 of 231 for:    CALCITONIN SALMON

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01329562
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Menstrual Migraine
Interventions Drug: Treximet
Drug: Placebo
Enrollment 41
Recruitment Details Subjects between the ages of 18 and 45 were recruited from two investigative sites. Subjects were enrolled from May 9,2011 through March 29, 2012. Last patient out June 5,2012.
Pre-assignment Details Subjects were enrolled and randomized at Visit 1. There were no significant events between enrollment and assignment.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Period Title: Overall Study
Started 20 21
Completed 11 14
Not Completed 9 7
Reason Not Completed
Protocol Violation             5             3
Lost to Follow-up             1             1
Subject withdrew due to personal issues.             3             2
Physician Decision             0             1
Arm/Group Title Placebo Treximet Total
Hide Arm/Group Description

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
21
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
34.35  (8.22) 36.71  (6.50) 35.56  (7.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
20
 100.0%
21
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 41 participants
20 21 41
1.Primary Outcome
Title Migraine Recurrence
Hide Description

Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.

0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe.

Time Frame From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: participants
0 2
2.Primary Outcome
Title Time to Pain Free
Hide Description

Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.

0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.

Time Frame From onset of 1 menstrual migraine headache until pain free.
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: hours
7.64  (4.06) 3.90  (3.92)
3.Primary Outcome
Title Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Hide Description

Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.

**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

Time Frame From Baseline until 2 hours post treatment of 1 menstrual migraine headache
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: pg/mL
VIP Baseline (n=10, 14) 763.6  (341.01) 1149.5  (532.07)
VIP Migraine Onset (n=10, 13) 1052.8  (490.57) 1111.31  (560.39)
VIP 2 Hours Post Treatment (n=9, 13) 1130.44  (600.29) 933.77  (643.38)
PGE2 Baseline (n=10, 14) 9.25  (7.97) 12.65  (11.33)
PGE2 Migraine Onset (n=10, 13) 7.56  (2.61) 13.02  (7.55)
PGE2 2 Hours Post Treatment (n=9, 14) 8.29  (4.43) 7.99  (4.37)
Cortisol Baseline (n=10, 13) 1064.14  (970.57) 1040.49  (1292.8)
Cortisol Migraine Onset (n=8, 13) 1084.85  (758.46) 1209.34  (1795.19)
Cortisol 2 Hours Post Treatment (n=8, 10) 2011.45  (2259.76) 418.48  (211.93)
PGI2 Baseline (n=10, 14) 109.51  (62.90) 160.27  (100.22)
PGI2 Migraine Onset (n=10, 13) 108.23  (61.25) 158.29  (76.74)
PGI2 2 Hours Post Treatment (n=9, 14) 97.58  (54.70) 201.60  (115.16)
Estradiol Baseline (n=10, 13) 63.37  (42.24) 62.61  (78.16)
Estradiol Migraine Onset (n=9, 13) 41.68  (30.43) 43.93  (36.85)
Estradiol 2 Hours Post Treatment (n=9,14) 54.07  (36.45) 41.66  (22.19)
4.Primary Outcome
Title CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Hide Description

CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache

* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

Time Frame From Baseline until 2 hours post treatment for 1 menstrual migraine headache
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: pmol/mg
CGRP Baseline (n=10, 14) 18.55  (16.98) 15.03  (11.73)
CGRP Migraine Onset (n=10, 13) 22.28  (14.45) 27.82  (36.66)
CGRP 2 Hours Post Treatment (n=9, 14) 14.92  (11.96) 21.38  (11.45)
5.Primary Outcome
Title α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Hide Description

α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache

* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

Time Frame From Baseline until 2 hours post treatment for 1 menstrual migraine headache
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: U/L
α-Amylase Baseline (n=10, 14) 109280.50  (12499.73) 99626.61  (7616.14)
α-Amylase Migraine Onset (n=10, 13) 100956.70  (13551.51) 98853.32  (12958.58)
α-Amylase 2 Hours Post Treatment (n=9, 14) 102449.80  (4883.00) 103594.90  (9335.72)
6.Primary Outcome
Title Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Hide Description

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.

* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.

**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

Time Frame From baseline to 24 hours post headache gone for 1 menstrual migraine headache.
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: pg/mL
VIP Migraine Onset (n=10,7,6) 1052.8  (490.57) 1111.31  (560.39)
VIP Migraine Headache Free (n=9,4,7) 964.4  (711.43) 949.7  (536.21)
VIP 24 Hours Migraine Headache Free (n=10,7,6) 1059.9  (564.42) 1353.04  (629.56)
PGE2 Migraine Onset (n=10,7,6) 7.56  (2.61) 13.02  (7.55)
PGE2 Migraine Headache Free (n=10,4,6,) 8.35  (6.52) 9.27  (6.74)
PGE2 24 Hours Migraine Headache Free (n=10,7,7) 10.46  (11.43) 13.04  (12.03)
Cortisol Migraine Onset (n=8,7,6) 1084.5  (7584.6) 1209.34  (1795.19)
Cortisol Migraine Headache Free (n=10,3,6) 1490.92  (2232.7) 1498.92  (1945.6)
Cortisol 24 Hours Migraine Headache Free(n=10,6,6) 1031.16  (1474.05) 1271.4  (1606.11)
PGI2 Migraine Onset (n=10,7,6) 108.23  (61.25) 158.29  (76.74)
PGI2 Migraine Headache Free (n=10,4,6) 115.63  (78.71) 167.48  (94.28)
PGI2 24 Hours Migraine Headache Free (n=10,7,7) 97.69  (63.84) 224.58  (160.51)
Estradiol Migraine Onset (n=9,7,6) 37.05  (31.67) 43.93  (36.85)
Estradiol Migraine Headache Free (n=9,4,5,) 48.83  (48.82) 39.92  (45.55)
Estradiol 24 Hours Migraine Headache Free(n=6,7,5) 21.34  (26.35) 56.33  (53.49)
7.Primary Outcome
Title CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Hide Description

CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.

* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

Time Frame From baseline to 24 hours post headache gone for 1 menstrual migraine headache
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: pmol/mg
CGRP Migraine Onset (n=10,7,6) 22.28  (14.45) 28.82  (36.66)
CGRP Migraine Headache Free (n=9,4,6) 22.55  (30.87) 32.26  (34.89)
CGRP 24 Hours Migraine Headache Free (n=9,7,7) 29.37  (26.76) 32.15  (27.74)
8.Primary Outcome
Title α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Hide Description

α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache

* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

Time Frame From baseline to 24 hours post headache gone for 1 menstrual migraine headache
Hide Outcome Measure Data
Hide Analysis Population Description
In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: U/L
α-Amylase Migraine Onset (n=10,7,6) 100956.70  (13551.51) 98853.32  (12958.58)
α-Amylase Migraine Headache Free (n=10,4,6) 102908.61  (11522.83) 101307.25  (8347.11)
α-Amylase 24 Hours Migraine Headache Free(n=10,7,7 100354.00  (16608.96) 102017.80  (8825.01)
9.Primary Outcome
Title Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Hide Description

Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache

*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.

Time Frame From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 11 14
Mean (Standard Deviation)
Unit of Measure: pg/mL
Urine Pre-Cycle Day 1 (n=3, 6) 2442.44  (545.38) 3090.92  (2306.67)
Urine Pre-Cycle Day 2 (n=6, 8) 4333.92  (2982.35) 2616.64  (2833.28)
Urine Pre-Cycle Day 3 (n=8, 6) 3582.92  (4121.17) 5089.63  (5775.30)
Urine Pre-Cycle Day 4 (n=9, 10) 3232.10  (2941.52) 3141.51  (2237.74)
Urine Migraine Headache Free (n=11, 13 2398.55  (1872.88) 2989.72  (3823.33)
Saliva Pre-Cycle Day 1 (n=1, 4) 41.75 [1]   (NA) 43.33  (23.19)
Saliva Pre-Cycle Day 2 (n=2, 6) 63.45  (57.60) 41.87  (17.73)
Saliva Pre-Cycle Day 3 (n=8, 10) 46.47  (34.73) 73.08  (58.17)
Saliva Pre-Cycle Day 4 (n=6, 9) 55.86  (50.17) 41.72  (31.69)
Saliva Migraine Headache Free (n=8, 6) 54.93  (48.38) 51.32  (45.64)
[1]
Only one subject's level was reportable for this single collection time point, therefore; mean and standard deviation could not be calculated with only one reported value.
10.Secondary Outcome
Title Migraine Recurrence Responders vs Non-Responders
Hide Description

Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.

0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe

*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From the onset of 1 menstrual migraine until 24 hours post treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 11 7 7
Measure Type: Number
Unit of Measure: participants
1 2 0
11.Secondary Outcome
Title Time to Pain-Free in Responders vs Non-Responders
Hide Description

Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.

0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.

*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From the onset of 1 menstrual migraine headache until pain-free.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: hours
7.64  (4.06) 3.13  (4.05) 4.68  (3.93)
12.Secondary Outcome
Title Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Hide Description

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.

*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.

**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: pg/mL
VIP Baseline (n=10,7,7) 763.6  (341.01) 1414.0  (618.96) 885.0  (258.91)
VIP Migraine Onset (n=10,7,6) 1052.8  (490.57) 1251.14  (580.38) 948.17  (538.67)
VIP 2 Hours Post Treatment (n=9,7,6,) 1130.44  (600.29) 1320.14  (657.68) 414.0  (226.53)
PGE2 Baseline (n=10,7,7) 9.25  (7.97) 14.29  (12.12) 11.01  (11.12)
PGE2 Migraine Onset (n=10,7,6) 7.56  (2.61) 14.13  (9.48) 11.72  (5.02)
PGE2 2 Hours Post Treatment (n=9,7,7) 8.29  (4.43) 6.83  (4.97) 9.15  (3.69)
Cortisol Baseline (n=10,6,7) 1064.14  (970.57) 790.77  (633.65) 1254.53  (1700.66)
Cortisol Migraine Onset (n=8,7,6) 1084.5  (758.46) 952.52  (864.35) 1508.97  (2576.41)
Cortisol 2 Hours Post Treatment (n=8,6,4) 2011.45  (2259.76) 482.32  (253.59) 322.72  (84.78)
PGI2 Baseline (n=10,7,7) 109.51  (62.90) 142.99  (65.71) 177.54  (129.41)
PGI2 Migraine Onset (n=10,7,6) 108.23  (61.25) 134.40  (71.0) 186.17  (79.71)
PGI2 2 Hours Post Treatment (n=9,7,7) 97.58  (54.70) 155.56  (63.48) 247.63  (140.58)
Estradiol Baseline (n=9,7,6) 63.37  (42.24) 49.60  (54.34) 66.68  (98.50)
Estradiol Migraine Onset (n=8,7,6) 37.05  (31.67) 44.89  (41.81) 42.81  (34.04)
Estradiol 2 Hours Post Treatment (n=8,7,7) 54.07  (36.45) 36.64  (23.20) 46.68  (21.67)
13.Secondary Outcome
Title CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders
Hide Description

CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.

*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: pmol/mg
CGRP Baseline (n=10,7,7) 18.55  (16.98) 12.27  (6.61) 17.80  (15.39)
CGRP Migraine Onset (n=10,7,6) 22.28  (14.45) 22.74  (11.94) 33.76  (54.55)
CGRP 2 Hours Post Treatment (n=9,7,7) 14.92  (11.96) 21.08  (8.02) 21.67  (14.81)
14.Secondary Outcome
Title α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Hide Description

α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.

*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline until 2 hours post treatment of 1 menstrual migraine headache.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: U/L
α-Amylase Baseline (n=10,7,7) 109280.50  (12499.73) 98002.68  (6613.71) 101250.54  (8705.42)
α-Amylase Migraine Onset (n=10,7,6) 100956.7  (13551.51) 103478.94  (10789.63) 93456.77  (14086.68)
α-Amylase 2 Hours Post Treatment (n=9,7,7) 102449.88  (4883.0) 103527.5  (12084.79) 103662.4  (6540.98)
15.Secondary Outcome
Title Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Hide Description

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.

*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.

**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: pg/mL
VIP Migraine Onset (n=10,7,6) 105.28  (490.97) 1251.14  (580.38) 948.97  (538.67)
VIP Migraine Headache Free (n=9,4,6) 964.4  (711.43) 1409.75  (567.81) 643.0  (204.69)
VIP 24 Hours Migraine Headache Free (n=10,7,5) 1059.9  (564.42) 1480.79  (624.74) 1174.2  (660.26)
PGE2 Migraine Onset (n=10,7,6) 7.56  (2.61) 14.13  (9.48) 11.72  (5.02)
PGE2 Migraine Headache Free (n=10,4,6) 8.35  (6.52) 7.87  (1.44) 10.21  (8.82)
PGE2 24 Hours Migraine Headache Free (n=10,7,7) 10.46  (11.43) 13.43  (14.38) 12.65  (10.31)
Cortisol Migraine Onset (n=8,7,6) 1084.5  (758.46) 952.52  (864.35) 1508.97  (2576.41)
Cortisol Migraine Headache Free (n=10,3,5) 1490.92  (2232.7) 592.35  (316.8) 2042.87  (2363.89)
Cortisol 24 Hours Migraine Headache Free(n=10,6,6) 1031.16  (1474.05) 863.09  (687.42) 1621.38  (2110.87)
PGI2 Migraine Onset (n=10,7,6) 108.23  (61.25) 134.40  (71.0) 186.17  (79.71)
PGI2 Migraine Headache Free (n=10,4,6) 115.63  (78.71) 154.16  (68.28) 176.37  (113.87)
PGI2 24 Hours Migraine Headache Free (n=10,7,7) 97.69  (63.84) 154.10  (71.61) 295.07  (197.73)
Estradiol Migraine Onset (n=9,7,6) 37.75  (31.67) 44.89  (41.81) 42.81  (34.04)
Estradiol Migraine Headache Free (n=9,5,4) 48.83  (48.82) 56.59  (67.39) 26.58  (15.60)
Estradiol 24 Hours Migraine Headache Free(n=6,7,6) 21.34  (26.35) 34.86  (46.64) 81.38  (53.46)
16.Secondary Outcome
Title CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Hide Description

CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.

*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline to 24 hours post headache gone for 1 menstrual migraine.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: pmol/mg
CGRP Migraine Onset (n=10,7,6) 22.28  (14.45) 22.74  (11.94) 33.76  (54.55)
CGRP Migraine Headache Free (n=9,4,6) 22.55  (30.87) 49.48  (49.68) 20.78  (17.73)
CGRP 24 Hours Migraine Headache Free (n=9,7,7) 29.37  (26.76) 28.43  (25.46) 35.87  (31.41)
17.Secondary Outcome
Title α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Hide Description

α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.

*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From Baseline from 24 hours post migraine gone for 1 menstrual migraine.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: U/L
α-amylase Migraine Onset (n=10,7,6) 100956.7  (13551.51) 103478.94  (10789.63) 93456.77  (14086.08)
α-amylase Migraine Headache Free (n=9,7,7) 102908.61  (11522.83) 98720.95  (13045.21) 103031.44  (3793.21)
α-amylase 24 Hours Migraine Headache Free(n=10,4,6 100354.3  (16608.96) 102475.8  (9769.4) 101559.9  (8532.96)
18.Secondary Outcome
Title Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Hide Description

Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.

*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.

***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.

A non-responder is one that fails to meet the responder criteria.

Time Frame From mid luteal phase and for the duration of 1 menstrual migraine until headache free.
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
Arm/Group Title Placebo Treximet Responder Treximet Non-Responder
Hide Arm/Group Description:

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: pg/mL
Urine Pre-Cycle Day 1 (n=3,2,4) 2442.44  (545.38) 1898.63  (92.07) 3687.07  (2728.27)
Urine Pre-Cycle Day 2 (n=6,3,5) 4333.92  (2982.35) 875.34  (377.69) 3661.52  (3215.32)
Urine Pre-Cycle Day 3 (n=8,2,5) 3582.92  (4121.17) 3739.44  (1536.97) 5629.71  (6940.06)
Urine Pre-Cycle Day 4 (n=9,5,5) 3232.10  (2941.52) 2016.99  (1295.30) 4266.02  (2535.29)
Urine Migraine Headache Free (n=10,7,7) 2398.55  (1872.88) 2542.09  (3152.52) 3373.40  (4536.70)
Saliva Pre-Cycle Day 1 (n=1,0,4) 41.75 [1]   (NA) NA [2]   (NA) 43.33  (23.19)
Saliva Pre-Cycle Day 2 (n=2,2,4) 63.45  (57.60) 30.89  (7.16) 47.36  (19.65)
Saliva Pre-Cycle Day 3 (n=8,4,7) 46.47  (34.73) 81.05  (60.64) 67.76  (61.65)
Saliva Pre-Cycle Day 4 (n=8,5,4) 55.86  (50.17) 31.71  (26.78) 54.22  (36.69)
Saliva Migraine Headache Free (n=8,3,4) 54.93  (48.38) 75.45  (68.38) 33.22  (5.48)
[1]
Only one Subject's level was reported for this time point, therefore; mean and standard deviation could not be calculated.
[2]
Unable to report for this group and time point as samples were not provided by any subjects in this group. Therefore, the mean and standard deviation could not be calculated.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Treximet
Hide Arm/Group Description

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Placebo : A placebo tablet matching Treximet for oral administration.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.

All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

All-Cause Mortality
Placebo Treximet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treximet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.2%
Placebo Treximet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      7/21 (33.33%)    
Cardiac disorders     
Chest Pain  1/20 (5.00%)  1 0/21 (0.00%)  0
Gastrointestinal disorders     
Dull Stomach Ache  0/20 (0.00%)  0 1/21 (4.76%)  1
General disorders     
Dry Mouth  1/20 (5.00%)  1 0/21 (0.00%)  0
Feeling of Upper Body Heaviness  1/20 (5.00%)  1 0/21 (0.00%)  0
Dizziness  1/20 (5.00%)  2 3/21 (14.29%)  4
Drowsiness  0/20 (0.00%)  0 1/21 (4.76%)  1
Hepatobiliary disorders     
Abnormal Alanine Aminotransferase (ALT)  1/20 (5.00%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Left Side Jaw Pain  1/20 (5.00%)  1 0/21 (0.00%)  0
Right Leg Cramping  0/20 (0.00%)  0 1/21 (4.76%)  1
Right Foot Pain [1]  0/20 (0.00%)  0 1/21 (4.76%)  1
Neck Pain  1/20 (5.00%)  1 0/21 (0.00%)  0
Shoulder Pain  1/20 (5.00%)  1 0/21 (0.00%)  0
Jaw Tightness  0/20 (0.00%)  0 1/21 (4.76%)  1
Chest Tightness  0/20 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders     
Shakiness  0/20 (0.00%)  0 1/21 (4.76%)  1
Worsening Headache  0/20 (0.00%)  0 1/21 (4.76%)  1
Head Pressure  1/20 (5.00%)  1 0/21 (0.00%)  0
Vascular disorders     
Flushing of Neck  1/20 (5.00%)  1 0/21 (0.00%)  0
Arms Felt Warm  1/20 (5.00%)  1 0/21 (0.00%)  0
Flushing of Face  1/20 (5.00%)  1 0/21 (0.00%)  0
[1]
Post bunionectomy
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Cady
Organization: Clinvest/A Division of Banyan Group Inc.
Phone: 417-890-7888
EMail: jtarrasch@clinvest.com
Layout table for additonal information
Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01329562     History of Changes
Other Study ID Numbers: 114680
First Submitted: March 17, 2011
First Posted: April 6, 2011
Results First Submitted: October 8, 2013
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014