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Treximet Early Intervention Adolescent Migraine (TEAM)

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ClinicalTrials.gov Identifier: NCT01016678
Recruitment Status : Completed
First Posted : November 19, 2009
Results First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Premiere Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Treximet
Drug: Placebo
Enrollment 104
Recruitment Details The study recruitment period started in March 2010 and the last subject was exited March 2013. The 4 sites who recruited all patients, consisted of 2 private practices and 2 children's hospital based site.
Pre-assignment Details 104 patients were randomized and dispensed study drug but only 94 of those patients actually treated at least one migraine, so therefore 94 subjects data was used in the analysis.
Arm/Group Title Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Hide Arm/Group Description

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

All migraines (up to four) will be treated with active treximet

Period Title: Overall Study
Started 20 17 19 19 19
Completed 18 14 15 19 13
Not Completed 2 3 4 0 6
Arm/Group Title Adolescents Age 12-17
Hide Arm/Group Description All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
104 subjects were randomized in the study but only 94 subjects actually dosed with study drug and completed at least one diary assessment post dose.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
<=18 years
104
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 104 participants
14.8
(12 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
65
  62.5%
Male
39
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants
104
1.Primary Outcome
Title Number of Participants With 2-hour Pain Free Active Study Drug
Hide Description All data was collected and measured from self-reported patient diaries
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis
Arm/Group Title Migraine Attack 1 Migraine Attack 2 Migraine Attack 3 Migraine Attack 4
Hide Arm/Group Description:

The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

Overall Number of Participants Analyzed 94 90 82 81
Measure Type: Number
Unit of Measure: Participants
Pain Free at 2 hours post dose for Active Treatmen 35 23 21 24
Pain Free at 2 Hours Post Dose for Placebo 2 2 3 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Migraine Attack 1, Migraine Attack 2, Migraine Attack 3, Migraine Attack 4
Comments Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 18
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
Hide Description All data was collected and measured from self-reported patient diaries
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours
Arm/Group Title Active Drug Placebo
Hide Arm/Group Description:
Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
Equivalent looking pill just like Treximet but only containing sugar, "sugar pill".
Overall Number of Participants Analyzed 54 13
Overall Number of Units Analyzed
Type of Units Analyzed: Migraines
103 13
Measure Type: Number
Unit of Measure: percentage of attacks
86 78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Drug, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1294
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 8
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
Hide Description All data was collected and measured from self-reported patient diaries
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks
Arm/Group Title Active Drug Placebo
Hide Arm/Group Description:
Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
Equivalent looking pill just like Treximet but only containing sugar, "sugar pill".
Overall Number of Participants Analyzed 94 74
Overall Number of Units Analyzed
Type of Units Analyzed: Number of migraine attacks
277 70
Measure Type: Number
Unit of Measure: percentage of attacks
32 18
4.Secondary Outcome
Title To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.
Hide Description Collected from patient reported paper diaries
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis data was not collected.
Arm/Group Title Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Hide Arm/Group Description:

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet

Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

All migraines (up to four) will be treated with active treximet

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Entire Study 3 years
Adverse Event Reporting Description All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
 
Arm/Group Title Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Hide Arm/Group Description Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All-Cause Mortality
Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/17 (0.00%)      0/19 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Nervous system disorders           
Prolonged Migraine * [1]  1/20 (5.00%)  1 0/17 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient was treated in the hospital for a prolonged migraine but it was not related to study drug. Study drug was taken 10 days prior to event onset.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active, Active, Active, Placebo Active, Active, Placebo, Active Active, Placebo, Active, Active Placebo, Active, Active, Active Active, Active, Active, Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      8/17 (47.06%)      5/19 (26.32%)      8/19 (42.11%)      7/19 (36.84%)    
Eye disorders           
Herpes Simplex Right Eye   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrointestinal disorders           
Nausea   1/20 (5.00%)  1 1/17 (5.88%)  1 2/19 (10.53%)  4 0/19 (0.00%)  0 1/19 (5.26%)  1
General disorders           
Tongue Swelling   0/20 (0.00%)  0 1/17 (5.88%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Burning Sensation Face   0/20 (0.00%)  0 1/17 (5.88%)  1 0/19 (0.00%)  0 1/19 (5.26%)  2 0/19 (0.00%)  0
Bad Taste   0/20 (0.00%)  0 0/17 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Weird Feeling, Out of Body Sensation   0/20 (0.00%)  0 1/17 (5.88%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Infections and infestations           
Abcess Right Leg   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Cough   1/20 (5.00%)  1 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Sinus Infection   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Neck Spasm/Tension * [1]  0/20 (0.00%)  0 1/17 (5.88%)  2 3/19 (15.79%)  3 0/19 (0.00%)  0 2/19 (10.53%)  4
Throat tightness * [2]  0/20 (0.00%)  0 1/17 (5.88%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1 3/19 (15.79%)  6
Stiff Jaw  [3]  0/20 (0.00%)  0 2/17 (11.76%)  3 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  2
Shoulder Pain   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  3
Bruised Coccyx   0/20 (0.00%)  0 1/17 (5.88%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Broken Right Arm   0/20 (0.00%)  0 1/17 (5.88%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Nervous system disorders           
Drowsiness * [4]  1/20 (5.00%)  1 2/17 (11.76%)  3 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  3
Dizziness   0/20 (0.00%)  0 1/17 (5.88%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  3
Numbness  [5]  0/20 (0.00%)  0 0/17 (0.00%)  0 2/19 (10.53%)  3 0/19 (0.00%)  0 1/19 (5.26%)  1
Psychiatric disorders           
Anxiety   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders           
Poison Ivy Rash   0/20 (0.00%)  0 0/17 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
The percentage of occurrence was 6.4%
[2]
The percentage of occurrence was 5%
[3]
Tightness or Stiff feeling in jaw
[4]
The percentage of occurrence was 4.3%
[5]
Numbness in Extremities
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: Paul Winner, DO
Organization: Premiere Research Institute
Phone: 561-845-0500 ext 102
EMail: pwinner777@aol.com
Layout table for additonal information
Responsible Party: Premiere Research Institute
ClinicalTrials.gov Identifier: NCT01016678     History of Changes
Other Study ID Numbers: TEAM2009
First Submitted: November 18, 2009
First Posted: November 19, 2009
Results First Submitted: October 19, 2015
Results First Posted: May 4, 2016
Last Update Posted: May 4, 2016