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NCT00644033 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 579
- Enrollment target
NCT00644033: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00644033 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 579 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644033, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 579 participants
- Enrollment target
Study Summary
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache. A statistically significant reduction in the incidence of MAM headache (p\<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p\<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.
Interventions
- DRUG Placebo
- DRUG Frovatriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2001-06 |
| Est. Completion | 2002-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644033
The ClinicalTrials.gov registry entry for NCT00644033 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 579 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00644033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00644033 about?
NCT00644033 is a clinical study titled "A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine". The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and d...
What is the current status of trial NCT00644033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2001-06. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00644033?
The interventions under investigation include: Placebo (DRUG), Frovatriptan (DRUG).
Who is sponsoring clinical trial NCT00644033?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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