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NCT01578941 · ClinicalTrials.gov registry record · Phase 4
An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
A Phase 4 study of Menstrual Migraine, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01578941: Completed Phase 4 study of Menstrual Migraine, sponsored by University of Alabama at Birmingham.
NCT01578941 is a Phase 4 study of Menstrual Migraine that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants, below the 279-participant average among 3 other Menstrual Migraine trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578941, a Phase 4 study of Menstrual Migraine, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.
Primary Outcome
Endpoints will include (a) total doses of study medication taken (primary endpoint), (b) total doses of rescue medication taken, (c) total "migraine days", (d) total "headache days", (e) days of functionally incapacitating headache, (f) work-related absenteeism, (g) unscheduled visits for acute headache treatment, (h) cost of unscheduled visits for acute headache treatment, (i) safety and tolerability, and (j) patient satisfaction.
Conditions Studied
Interventions
- OTHER Diary
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
What the finished NCT01578941 record still lists
NCT01578941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 279-participant average among 3 other Menstrual Migraine trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Menstrual Migraine appearing as the primary indexed condition, and to 1 intervention - of which Diary is the first listed.
NCT01578941 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT01578941 about?
NCT01578941 is a clinical study titled "An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine". The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.
What is the current status of trial NCT01578941?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2011-01. Estimated completion is 2012-09.
What conditions does trial NCT01578941 study?
This clinical trial studies the following conditions: Menstrual Migraine.
What interventions are being tested in trial NCT01578941?
The interventions under investigation include: Diary (OTHER).
Who is sponsoring clinical trial NCT01578941?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01578941 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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