A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

Allergan

Status and phase: Completed; Phase 4

Conditions: Migraine Disorders

Treatments: Biological: onabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516892

GMA-BTX-CM-10-001

The COMPEL Study (Other Identifier)

Details and patient eligibility

About

This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Enrollment: 716 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

Exclusion criteria

• Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis
• Headache attributed to another disorder
• Infection or skin disorder at injection sites
• Previous treatment with botulinum toxin of any serotype for any reason
• Anticipated need for botulinum toxin of any type for any reason during the course of the study
• Previous participation in any botulinum toxin clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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716 participants in 1 patient group

BOTOX®

Experimental group

Description:

Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.

Treatment:

Biological: onabotulinumtoxinA