Treximet Early Intervention Adolescent Migraine (TEAM)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Premiere Research Institute
ClinicalTrials.gov Identifier:
NCT01016678
First received: November 18, 2009
Last updated: March 31, 2016
Last verified: March 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: Treximet
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Active, Active, Active, 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 three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo

Active, Active, Placebo, Active

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

Active, Placebo, Active, Active

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

Placebo, Active, Active, Active

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

Active, Active, Active, Active

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


Participant Flow:   Overall Study
    Active, Active, Active, Placebo     Active, Active, Placebo, Active     Active, Placebo, Active, Active     Placebo, Active, Active, Active     Active, Active, Active, Active  
STARTED     20     17     19     19     19  
COMPLETED     18     14     15     19     13  
NOT COMPLETED     2     3     4     0     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Adolescents Age 12-17 All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average

Baseline Measures
    Adolescents Age 12-17  
Number of Participants  
[units: participants]
  104  
Age  
[units: participants]
 
<=18 years     104  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean (Full Range)
  14.8  
  (12 to 17)  
Gender  
[units: participants]
 
Female     65  
Male     39  
Region of Enrollment  
[units: participants]
 
United States     104  



  Outcome Measures
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1.  Primary:   Number of Participants With 2-hour Pain Free Active Study Drug   [ Time Frame: 3 years ]

2.  Primary:   Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose   [ Time Frame: 3 years ]

3.  Primary:   Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention   [ Time Frame: 3 years ]

4.  Secondary:   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.   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Paul Winner, DO
Organization: Premiere Research Institute
phone: 561-845-0500 ext 102
e-mail: pwinner777@aol.com



Responsible Party: Premiere Research Institute
ClinicalTrials.gov Identifier: NCT01016678     History of Changes
Other Study ID Numbers: TEAM2009
Study First Received: November 18, 2009
Results First Received: October 19, 2015
Last Updated: March 31, 2016
Health Authority: United States: Food and Drug Administration