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NCT01300546 · ClinicalTrials.gov registry record · Phase 4
Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
A Phase 4 study, sponsored by Cady, Roger, M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT01300546: Completed Phase 4 study, sponsored by Cady, Roger, M.D..
NCT01300546 is a Phase 4 study that has completed, run by Cady, Roger, M.D.. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300546, a Phase 4 study, has completed, sponsored by Cady, Roger, M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.
Primary Outcome
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%).
Interventions
- DRUG Naproxen Sodium
- DRUG Sumatriptan/Naproxen Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01300546 record still lists
NCT01300546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Naproxen Sodium is the first listed.
NCT01300546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300546 about?
NCT01300546 is a clinical study titled "Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine". This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.
What is the current status of trial NCT01300546?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2010-12. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01300546?
The interventions under investigation include: Naproxen Sodium (DRUG), Sumatriptan/Naproxen Sodium (DRUG).
Who is sponsoring clinical trial NCT01300546?
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 NCT01300546's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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