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| Sponsor: | NeurAxon Inc. |
|---|---|
| Information provided by: | NeurAxon Inc. |
| ClinicalTrials.gov Identifier: | NCT00920686 |
Purpose
NXN-188 Dihydrochloride is being developed as an immediate release oral product for the treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects with a migraine history of aura.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine With Aura |
Drug: NXN-188 Drug: placebo Drug: sumatriptan succinate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 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 With Aura |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 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
NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
|
| sumatriptan succinate 100 mg: Active Comparator |
Drug: sumatriptan succinate
administered in hard gelatine capsule
|
| placebo: Placebo Comparator |
Drug: placebo
3 placebo hard gelatin capsules
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have a headache history of migraine with aura as defined by:
Aura consisting of at least one of the following, but no muscle weakness or paralysis:
Aura has at least two of the following characteristics:
Headache frequency of at least 1 migraine attack (with or without aura) per month for the past 3 months but not more than 8 migraines in any 30 day period. Subjects must have at least 1 migraine headache with aura per month
• Each migraine attack should last at least 4 hours (without treatment) and not longer than 72 hours.
The subject is in general good health.
• ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits
Exclusion Criteria:
Use of the following if taken for migraine prevention:
Contacts and Locations| United States, California | |
| C. Philip O'Carrroll, MD, Inc. | |
| Newport Beach, California, United States, 92660 | |
| San Francisco Headache Clinic | |
| San Francisco, California, United States, 94109 | |
| California Medical Clinic for Headache | |
| Santa Monica, California, United States, 90404 | |
| The Research Center of Southern California, LLC | |
| Oceanside, California, United States, 92056 | |
| United States, Florida | |
| Comprehensive Neuroscience, Inc. | |
| St. Petersburg, Florida, United States, 33702 | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Michigan | |
| Michigan Head-Pain and Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Missouri | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| Headache Care Center/Clinvest | |
| Springfield, Missouri, United States, 65807 | |
| United States, Nebraska | |
| Meridian Clinical Research, LLC | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New York | |
| Rochester Clinical Research, Inc | |
| Rochester, New York, United States, 14609 | |
| Elkind Headache Center | |
| Mount Vernon, New York, United States, 10550 | |
| Regional Clinical Research, Inc. | |
| Endwell, New York, United States, 13760 | |
| United States, North Carolina | |
| Headache Wellness Center | |
| Greensboro, North Carolina, United States, 27405 | |
| United States, South Carolina | |
| Coastal Carolina Research Center, Inc | |
| Mt. PLeasant, South Carolina, United States, 29464 | |
| United States, Utah | |
| Advanced Clinical Research, Inc. | |
| West Jordan, Utah, United States, 84088 | |
| Principal Investigator: | Guy Boudreau, MD | Hopital Notre-Dame Du Chum, Montreal |
More Information
| Responsible Party: | NeurAxon, Inc ( Robert Medve, MD ) |
| Study ID Numbers: | NXN-188-203 |
| Study First Received: | June 12, 2009 |
| Last Updated: | October 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00920686 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Migraine aura |
|
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents Brain Diseases |
Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents Migraine with Aura |