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| Sponsored by: |
Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00660192 |
Purpose
The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50% and more and this effect is even more positive after second treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Migraine |
Drug: Botulinum toxin A |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
arm 1: compares the effect of Botox with placebo (blinded protocol)
|
Drug: Botulinum toxin A
Series of injections of botulinum toxin totalling 200 to 300 units vs placebo. Final dose is determined by based size of patient and patient neck size.
|
|
2: Active Comparator
Arm 2- Open label- every subject receives Botox
|
Drug: Botulinum toxin A
Open label arm with injection of active drug via a series of injections as used in Arm 1 (closed label). A series of intramuscular injections totalling 200 to 300 units of toxin administered.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Diana Richardson, M.D. | (203) 737-1831 | diana.richardson@yale.edu |
| Contact: Diana Miller, M.D. | (203) 737-1831 | diana.miller@yale.edu |
| United States, Connecticut | |
| Yale Neurology Clinic, 6C, 40 Temple Street | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: Bahman Jabbari, M.D | |
| Principal Investigator: Bahman Jabbari, M.D. | |
| Principal Investigator: | Bahman Jabbari, M.D. | Yale University |
More Information
| Responsible Party: | Yale University School of Medicne ( Bahman Jabbari, Professor of Neurology ) |
| Study ID Numbers: | 0709003056 |
| Study First Received: | April 10, 2008 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00660192 |
| Health Authority: | United States: Institutional Review Board |
|
Migraine, refractory migraine, Pain, Botulinum Toxin , Botox |
|
Botulinum Toxins Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Pain Botulinum Toxin Type A Brain Diseases Headache Disorders |
|
Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |
