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Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

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: NCT01300546
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
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: Prevention
Condition Migraine
Interventions Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium
Enrollment 40
Recruitment Details Recruitment period was from date of Institutional Review Board (IRB) approval (11-30-10) until date last patient enrolled (1/3/12). Subjects were recruited from general population at two clinical research centers.
Pre-assignment Details Subjects must complete a 30 day Baseline Period between Visit 1 and Visit 2 before Randomization. Subjects must have had 6-14 headache days during the 30 day Baseline Period in order to be Randomized into the Study Treatment Period. Fifty nine subjects were screened for study; however, only 39 subjects randomized for treatment due to screen fail.
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache. In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Period Title: Overall Study
Started 19 20
Completed 18 14
Not Completed 1 6
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             2
Lack of Efficacy             0             3
Adverse Event             0             1
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium Total
Hide Arm/Group Description In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache. In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache. Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
20
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
35.7  (9.6) 43.1  (9.3) 39.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
17
  89.5%
19
  95.0%
36
  92.3%
Male
2
  10.5%
1
   5.0%
3
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 20 participants 39 participants
19 20 39
1.Primary Outcome
Title Percent Change of Headache Days Compared to Baseline
Hide Description Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).
Time Frame Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of headache days
-13.50  (34.80) -36.50  (36.48)
2.Secondary Outcome
Title Migraine Attacks
Hide Description Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of migraine attacks
Baseline to Treatment Period Month 1 -4.35  (32.63) -12.23  (31.27)
Baseline to Treatment Period Month 2 -2.88  (37.59) -9.03  (25.69)
Baseline to Treatment Period Month 3 -8.63  (38.10) -39.12  (30.28)
3.Secondary Outcome
Title Migraine Severity
Hide Description Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of migraine severity
2 hours after treatment for Baseline to Month 1 -17.84  (72.91) 11.78  (79.60)
2 hours after treatment for Baseline to Month 2 -36.71  (49.78) 0.33  (54.96)
2 hours after treatment for Baseline to Month 3 -55.60  (52.92) 32.62  (107.62)
4.Secondary Outcome
Title Migraine Duration From Onset to Pain Free
Hide Description Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of migraine duration
Baseline to Treatment Period Month 1 72.04  (214.89) -14.92  (75.02)
Baseline to Treatment Period Month 2 35.86  (178.63) -26.35  (47.97)
Baseline to Treatment Period Month 3 61.96  (304.74) 70.84  (221.11)
5.Secondary Outcome
Title Migraine Duration From Time of Treatment to Pain Free
Hide Description

% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%).

Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of migraine duration
Baseline to Treatment Period Month 1 150.10  (366.03) -14.91  (76.85)
Baseline to Treatment Period Month 2 92.73  (261.37) -25.52  (49.62)
Baseline to Treatment Period Month 3 114.10  (354.77) 73.42  (224.71)
6.Secondary Outcome
Title Headache Days With Greater Than 50% Reduction
Hide Description Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Measure Type: Number
Unit of Measure: participants
Baseline to Treatment Period Month 1 1 3
Baseline to Treatment Period Month 2 2 3
Baseline to Treatment Period Month 3 3 6
7.Secondary Outcome
Title Migraine Attacks With 50% Reduction
Hide Description Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Measure Type: Number
Unit of Measure: participants
Baseline to Treatment Period Month 1 3 1
Baseline to Treatment Period Month 2 2 0
Baseline to Treatment Period Month 3 4 6
8.Secondary Outcome
Title Doses of Study Medication
Hide Description Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Time Frame Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: doses of study medication
Treatment Period Month 1 11.00  (3.94) 9.36  (5.53)
Treatment Period Month 2 10.28  (6.39) 8.86  (5.17)
Treatment Period Month 3 10.28  (7.08) 8.50  (6.04)
9.Secondary Outcome
Title Percent Change of Doses of Study Medication
Hide Description % change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.
Time Frame Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
12 Subjects did not take any triptans (Group A) or NSAIDs (Group B) during Baseline Period and were not included in Matched Pairs analysis of study medication taken.
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: percent change of study medication
Baseline to Treatment Period Month 1 130.8  (240.8) 160.8  (399.2)
Baseline to Treatment Period Month 2 114.9  (197.1) 76.4  (152.5)
Baseline to Treatment Period Month 3 96.1  (208.0) 112.7  (228.0)
10.Secondary Outcome
Title Migraine Disability Assessment Test (MIDAS)
Hide Description

Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

Total score of disability ranges:

  • 0 to 5, MIDAS Grade I, Little or no disability
  • 6 to 10, MIDAS Grade II, Mild disability
  • 11 to 20, MIDAS Grade III, Moderate disability
  • 21+, MIDAS Grade IV, Severe disability No subscales are present.
Time Frame Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Day 31 28.7  (36.7) 22.6  (21.6)
Day 121 27.9  (20.3) 24.1  (22.5)
11.Secondary Outcome
Title Compliance With Lifestyle Changes
Hide Description Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Time Frame Day 121
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.33  (0.69) 2.43  (0.76)
12.Secondary Outcome
Title Percent Change in Headache Days All Treatment Periods Compared to Baseline
Hide Description Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: percent change of migraine headache days
Baseline to Treatment Period Month 1 -1.70  (37.94) -26.86  (31.74)
Baseline to Treatment Period Month 2 -4.39  (43.66) -21.44  (28.79)
Baseline to Treatment Period Month 3 -13.50  (34.80) -36.50  (36.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache. In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
All-Cause Mortality
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/19 (26.32%)      6/20 (30.00%)    
Gastrointestinal disorders     
Diarrhea   1/19 (5.26%)  1 0/20 (0.00%)  0
Vomiting   0/19 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications     
Root Canal Pain   1/19 (5.26%)  1 0/20 (0.00%)  0
Wisdom Teeth Extraction Pain   0/19 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders     
Weight Gain   1/19 (5.26%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain   0/19 (0.00%)  0 1/20 (5.00%)  1
Left Arm Pain   0/19 (0.00%)  0 1/20 (5.00%)  2
Neck Pain   0/19 (0.00%)  0 1/20 (5.00%)  2
Right Chest Wall Pain   0/19 (0.00%)  0 1/20 (5.00%)  1
Stiffness in neck   1/19 (5.26%)  1 0/20 (0.00%)  0
Nervous system disorders     
Allodynia  [1]  1/19 (5.26%)  82 0/20 (0.00%)  0
Left Arm Numbness   0/19 (0.00%)  0 1/20 (5.00%)  1
Left Hand Numbness   0/19 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Insomnia   1/19 (5.26%)  1 0/20 (0.00%)  0
Renal and urinary disorders     
Kidney Stone Pain Flare   0/19 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis   1/19 (5.26%)  1 0/20 (0.00%)  0
Cough   1/19 (5.26%)  1 0/20 (0.00%)  0
Nasal Congestion   1/19 (5.26%)  1 0/20 (0.00%)  0
Sinusitis   1/19 (5.26%)  1 1/20 (5.00%)  2
Skin and subcutaneous tissue disorders     
Fever   1/19 (5.26%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Allodynia reported by one patient for 2 hours after every administration of study medication.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Jeanne Tarrasch
Organization: Clinvest/A Division of Banyan Group Inc.
Phone: 417-841-3673
Publications:
Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01300546     History of Changes
Other Study ID Numbers: 114933
First Submitted: January 12, 2011
First Posted: February 21, 2011
Results First Submitted: February 1, 2013
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013