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Ictal and Interictal Inflammatory Markers in Migraine

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ClinicalTrials.gov Identifier: NCT01138150
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborators:
University of Toledo Health Science Campus
The Cleveland Clinic
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Condition Migraine
Interventions Drug: Treximet
Drug: Placebo
Enrollment 36
Recruitment Details

Dates of recruitment - December 9 2010 through January 22, 2013.

Types of location - Neurology Headache Clinic, Internal Medicine Clinics, Gynecology clinic; study flyers placed in the medical offices , Johns Hopkins Community Physicians sites, academic institutions and wellness centers.

Pre-assignment Details  
Arm/Group Title Active Drug - Sumatriptan/Naproxen Placebo
Hide Arm/Group Description Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack Participants randomized to placebo upon presentation with acute migraine attack.
Period Title: Overall Study
Started 18 18
Completed 17 17
Not Completed 1 1
Reason Not Completed
blood unable to be processed             0             1
Physician Decision             1             0
Arm/Group Title Treximet Sugar Pill Total
Hide Arm/Group Description Participants randomized to active drug Treximet during acute migraine attack. Participants randomized to placebo (sugar pill) during acute migraine attack. Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
17
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
17
 100.0%
15
  88.2%
32
  94.1%
Male
0
   0.0%
2
  11.8%
2
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.9%
1
   5.9%
2
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.8%
1
   5.9%
3
   8.8%
White
14
  82.4%
15
  88.2%
29
  85.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in the Total Serum Adiponectin (T-ADP)
Hide Description Change in total serum adiponectin after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Responders 60 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 120 Minutes After Treatment Treatment Non-Responders
Hide Arm/Group Description:
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
-0.96
(-1.84 to -0.08)
0.25
(-1.85 to 2.37)
-0.97
(-1.85 to -0.08)
0.29
(-1.88 to 2.46)
-0.98
(-1.88 to -0.08)
0.24
(-1.95 to 2.44)
2.Secondary Outcome
Title High Molecular Weight (HMW)-Adiponectin (ADP)
Hide Description serum HMW-ADP levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
-0.24
(-0.47 to -0.01)
-0.08
(-0.76 to 0.61)
-0.23
(-0.46 to -0.01)
-0.14
(-0.79 to 0.52)
-0.24
(-0.91 to 0.44)
-0.21
(-0.44 to 0.01)
3.Secondary Outcome
Title Middle Molecular Weight (MMW)-ADP
Hide Description serum MMW-ADP levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
-0.02
(-0.25 to 0.22)
0.02
(-0.19 to 0.24)
-0.03
(-0.26 to 0.21)
-0.02
(-0.23 to 0.19)
0.16
(-0.05 to 0.38)
-0.03
(-0.26 to 0.21)
4.Secondary Outcome
Title Low Molecular Weight (LMW)-ADP
Hide Description serum LMW-ADP levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
0.32
(0.03 to 0.60)
-0.43
(-0.75 to -0.11)
0.15
(-0.13 to 0.42)
-0.25
(-0.57 to 0.06)
-0.45
(-0.77 to -0.14)
0.11
(-0.17 to 0.39)
5.Secondary Outcome
Title High Molecular Weight (HMW): T-ADP
Hide Description serum HMW:T-ADP levels after treatment in responders and non responders
Time Frame 30 minutes, 60 minutes, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ratio
-0.04
(-0.07 to -0.01)
0.01
(-0.03 to 0.06)
-0.02
(-0.06 to 0.01)
0.01
(-0.04 to 0.05)
0.01
(-0.05 to 0.05)
-0.02
(-0.05 to 0.02)
6.Secondary Outcome
Title Low Molecular Weight (LMW):Total (T)-ADP
Hide Description serum LMW:T-ADP levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ratio
0.04
(0.01 to 0.07)
-0.04
(-0.07 to -0.01)
-0.01
(-0.05 to 0.02)
0.02
(-0.02 to 0.05)
-0.04
(-0.07 to -0.01)
0.01
(-0.02 to 0.05)
7.Secondary Outcome
Title Leptin
Hide Description serum leptin levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
0.71
(-1.55 to 2.97)
0.89
(-0.93 to 2.71)
0.28
(-1.93 to 2.50)
0.84
(-0.91 to 2.59)
1.00
(-0.80 to 2.80)
0.02
(-2.21 to 2.24)
8.Secondary Outcome
Title Resistin
Hide Description serum resistin levels after treatment in responders and non responders
Time Frame 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Responders 120 Minutes After Treatment Treatment Non Responders 120 Minutes After Treatment Treatment Responders 30 Minutes After Treatment Treatment Non-Responders 30 Minutes After Treatment Treatment Non-Responders 60 Minutes After Treatment Treatment Responders 60 Minutes After Treatment
Hide Arm/Group Description:
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Participants without reduction in pain at 120 minutes after treatment
Participants without reduction in pain at 120 minutes after treatment
Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
Overall Number of Participants Analyzed 17 17 17 17 17 17
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
-0.95
(-1.83 to -0.07)
-0.97
(-3.95 to 2.00)
-1
(-1.86 to -0.14)
-0.88
(-3.75 to 1.98)
-1.36
(-4.30 to 1.59)
-0.79
(-1.65 to 0.08)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treximet Sugar Pill
Hide Arm/Group Description sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn. Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
All-Cause Mortality
Treximet Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treximet Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treximet Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
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
Name/Title: Dr. Lee Peterlin
Organization: The Johns Hopkins University School of Medicine
Phone: 410-550-5452
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01138150     History of Changes
Obsolete Identifiers: NCT00868322
Other Study ID Numbers: GSK112035
First Submitted: June 3, 2010
First Posted: June 7, 2010
Results First Submitted: February 9, 2016
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016