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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
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.
Other Name: Botox.
|
|
Active Comparator: 2
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.
Other Name: Botox.
|
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: Laura Marshall | (203) 785-5420 | laura.marshall@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: | Bahman Jabbari, Professor of Neurology, Yale University School of Medicne |
| ClinicalTrials.gov Identifier: | NCT00660192 History of Changes |
| Other Study ID Numbers: | 0709003056 |
| Study First Received: | April 10, 2008 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Migraine, refractory migraine, Pain, Botulinum Toxin , Botox |
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
