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NCT01016678 · ClinicalTrials.gov registry record · Phase 2
Treximet Early Intervention Adolescent Migraine
A Phase 2 study of Migraine, sponsored by Premiere Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 4
- Study locations
NCT01016678: Completed Phase 2 study of Migraine, sponsored by Premiere Research Institute.
NCT01016678 is a Phase 2 study of Migraine that has completed, run by Premiere Research Institute. The registered enrollment target is 104 participants, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (71% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01016678, a Phase 2 study of Migraine, has completed, sponsored by Premiere Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 4
- Study locations
Study Summary
The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.
Primary Outcome
All data was collected and measured from self-reported patient diaries
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Treximet
Study Locations (4)
Florida
- Premiere Research Institute - West Palm Beach
Ohio
- Andrew Hershey - Cincinnati
Texas
- Steve L. Linder - Dallas
Virginia
- Don W. Lewis - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01016678 record still lists
NCT01016678 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01016678 reports a single indexed study location in Florida, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT01016678 about?
NCT01016678 is a clinical study titled "Treximet Early Intervention Adolescent Migraine". The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to ei...
What is the current status of trial NCT01016678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2010-03. Estimated completion is 2014-07.
What conditions does trial NCT01016678 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT01016678?
The interventions under investigation include: Placebo (DRUG), Treximet (DRUG).
Who is sponsoring clinical trial NCT01016678?
This trial is sponsored by Premiere Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01016678 being conducted?
This trial has 4 study locations across Florida, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01016678's enrollment target sits among peer trials
104 57th of 102 higher than 46 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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