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NCT01432379 Clinical Trial

BOTOX® Prophylaxis in Patients With Chronic Migraine

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01432379
Other study ID # 191622-110
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2011
Est. completion date May 12, 2015

Study information
Verified date December 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a post authorization 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.

Recruitment information / eligibility
Status Completed
Enrollment 1168
Est. completion date May 12, 2015
Est. primary completion date May 12, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of chronic migraine

- Willing to use BOTOX® as preventative treatment for migraine

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

Germany,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Matharu M, Pascual J, Nilsson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Rate of Dysphagia Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing. 64 weeks
Secondary Incidence Rate of Intractable Migraine Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away. 64 weeks
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