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| Sponsor: | NeurAxon Inc. |
|---|---|
| Information provided by: | NeurAxon Inc. |
| ClinicalTrials.gov Identifier: | NCT00959751 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Without Aura |
Drug: NXN-188 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2 Study of the Safety and Effectiveness of a Single Oral Dose of NXN-188 for the Treatment of Moderate to Severe Migraine Headache Without Aura |
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| NXN-188: Experimental |
Drug: NXN-188
capsules, 600 mg, PRN
|
| Placebo: Placebo Comparator |
Drug: Placebo
capsules, PRN
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A diagnosis of headaches that is not consistent with migraine without aura as defined in the inclusion criteria. Subjects with a history of migraine with aura are excluded.
Contacts and Locations| Contact: Robert A Medve, MD | rmedve@neuraxon.com |
| United States, Florida | |
| Comprehensive Neuroscience, Inc. | Recruiting |
| St. Petersburg, Florida, United States, 33716 | |
| Contact: Judith Shea 727-576-8474 jshea@cnsmail.com | |
| Contact: Susan Montgomery 727-576-8474 smontgomery@cnsmail.com | |
| Principal Investigator: Margarita Nunez, MD | |
| United States, Georgia | |
| Comprehensive NeuroScience, Inc. Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| Contact: Ghimja Berhanu 404-459-6699 | |
| Principal Investigator: Brian Bortnick, MD | |
| United States, New York | |
| Elkind Headache Center | Recruiting |
| Mount Vernon, New York, United States, 10550 | |
| Contact: Arthur Elkind, MD 914-667-2230 arthur.elkind@verizon.net | |
| Principal Investigator: Arthur H Elkind, MD | |
| United States, Utah | |
| Lifetree Clinical Research | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| Contact: Alice Jackson 801-269-8200 alicej@lifetreerersearch.com | |
| Principal Investigator: Lynn Webster, MD | |
| Principal Investigator: | Guy Boudreau, MD | Hopital Notre-Dame Du Chum, Montreal |
More Information
| Responsible Party: | NeurAxon, Inc ( Robert A. Medve, M.D. ) |
| Study ID Numbers: | NXN-188-204 |
| Study First Received: | August 14, 2009 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00959751 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
migraine |
|
Headache Disorders, Primary Migraine without Aura Nervous System Diseases Central Nervous System Diseases |
Headache Disorders Migraine Disorders Brain Diseases |