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| Sponsor: | Allergan |
|---|---|
| Information provided by (Responsible Party): | Allergan |
| ClinicalTrials.gov Identifier: | NCT01432379 |
Purpose
This is a postauthorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
| Condition | Intervention |
|---|---|
|
Migraine Disorders |
Biological: botulinum toxin Type A |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
botulinum toxin Type A
|
Biological: botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year
Other Name: BOTOX®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Chronic Migraine
Inclusion Criteria:
Contacts and Locations| Contact: Allergan Inc. | clinicaltrials@allergan.com |
| United Kingdom | |
| Recruiting | |
| London, United Kingdom | |
| Study Director: | Medical Director | Allergan |
More Information
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01432379 History of Changes |
| Other Study ID Numbers: | 191622-110 |
| Study First Received: | September 9, 2011 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases 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 |