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

Phase 4

Completed

• Conditions: Migraine Disorders

• Registration Number: NCT01516892
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-11
• Results First Submitted: 2016-11-09
• Results First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Results First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Frequency of Headache Days	Baseline, Week 108	Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Frequency of Headache Days	Baseline, Week 60	Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score	Baseline, Week 60, Week 108	The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.

Trial Locations

Locations (32)

Arizona Neurological Institute; 🇺🇸 Scottsdale, Arizona, United States

The Research Center of Southern California, LLC; 🇺🇸 Encinitas, California, United States

USC Neurology; 🇺🇸 Los Angeles, California, United States

UCSF Headache Center; 🇺🇸 San Francisco, California, United States

Neurological Research Institute; 🇺🇸 Santa Monica, California, United States

Advanced Neurosciences Research, LLC; 🇺🇸 Fort Collins, Colorado, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Premiere Research Institute at Palm Beach Neurology; 🇺🇸 West Palm Beach, Florida, United States

Robbins Headache Clinic; 🇺🇸 Northbrook, Illinois, United States

Mid-Atlantic Headache Institute; 🇺🇸 Baltimore, Maryland, United States

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