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NCT00959751 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura
A Phase 2 study of Migraine Without Aura, sponsored by NeurAxon.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
- 4
- Study locations
NCT00959751: Completed Phase 2 study of Migraine Without Aura, sponsored by NeurAxon.
NCT00959751 is a Phase 2 study of Migraine Without Aura that has completed, run by NeurAxon. The registered enrollment target is 195 participants, above the 142-participant average among 6 other Migraine Without Aura trials with a reported enrollment target (37% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00959751, a Phase 2 study of Migraine Without Aura, has completed, sponsored by NeurAxon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migraine without aura will complete each of the two treatment arms to evaluate NXN-188 600 mg or placebo.
Primary Outcome
Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NXN-188
Study Locations (4)
Florida
- Comprehensive Neuroscience, Inc. - St. Petersburg
Georgia
- Comprehensive NeuroScience, Inc. Atlanta - Atlanta
New York
- Elkind Headache Center - Mount Vernon
Utah
- Lifetree Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00959751 record still lists
NCT00959751 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 6 other Migraine Without Aura trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Migraine Without Aura appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00959751 reports a single indexed study location in Florida, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT00959751 about?
NCT00959751 is a clinical study titled "Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura". This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migrain...
What is the current status of trial NCT00959751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2009-07. Estimated completion is 2010-03.
What conditions does trial NCT00959751 study?
This clinical trial studies the following conditions: Migraine Without Aura.
What interventions are being tested in trial NCT00959751?
The interventions under investigation include: Placebo (DRUG), NXN-188 (DRUG).
Who is sponsoring clinical trial NCT00959751?
This trial is sponsored by NeurAxon, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00959751 being conducted?
This trial has 4 study locations across Florida, Georgia, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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