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NCT01053507 · ClinicalTrials.gov registry record · Phase 4
Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
A Phase 4 study, sponsored by Cady, Roger, M.D..
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT01053507: Clinical Trial Phase 4 study, sponsored by Cady, Roger, M.D..
NCT01053507 is a Phase 4 study that was terminated before completion, run by Cady, Roger, M.D.. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053507, a Phase 4 study, was terminated before completion, sponsored by Cady, Roger, M.D..
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.
Primary Outcome
Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.
Interventions
- DRUG Placebo
- DRUG sumatriptan/naproxen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
Why NCT01053507 stopped before completion
NCT01053507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01053507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01053507 about?
NCT01053507 is a clinical study titled "Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction". This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, s...
What is the current status of trial NCT01053507?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2010-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01053507?
The interventions under investigation include: Placebo (DRUG), sumatriptan/naproxen sodium (DRUG).
Who is sponsoring clinical trial NCT01053507?
This trial is sponsored by Cady, Roger, M.D., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01053507's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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