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

Phase 4

Completed

• Conditions: Migraine Disorders
• Interventions: Biological: onabotulinumtoxinA

• 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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BOTOX®	onabotulinumtoxinA	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.

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)

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

Ohio Clinical Research Partners, LLC; 🇺🇸 Canton, Ohio, United States

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States

Wesley Headache Clinic; 🇺🇸 Cordova, Tennessee, United States

Renown Institute for Neurosciences; 🇺🇸 Reno, Nevada, United States

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

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

Kangbuk Samsung Hospital; 🇰🇷 Jongno-Gu, Seoul, Korea, Republic of

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

Mercy Health Research; 🇺🇸 St. Louis, Missouri, United States

Associate Professor Richard Stark; 🇦🇺 Melbourne, Australia

Dent Neurologic Institute; 🇺🇸 Amherst, New York, United States

Hallym University Sacred Heart Hospital; 🇰🇷 Dongan-gu, Anyang, Anyang Gyeonggi-do, Korea, Republic of

Seoul Eulji Hospital; 🇰🇷 Nowon-Gu, Seoul, Korea, Republic of

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

Richmmond Neurology; 🇦🇺 Richmond, Australia

Kaiser Permanente Research Office/Neurology Department; 🇺🇸 Largo, Maryland, United States

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

Clinvest Research; 🇺🇸 Springfield, Missouri, United States

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

Dr. Con Yiannikas; 🇦🇺 Burwood, Australia

Seoul St. Mary's Hospital; 🇰🇷 Jongno-Gu, Seoul, Korea, Republic of

Associate Professor John O'Sullivan; 🇦🇺 Spring Hill, Australia

Dr. Joseph Frasca; 🇦🇺 Adelaide, Australia

Yonsei University Dental Hospital; 🇰🇷 Seodaemum-Gu, Seoul, Korea, Republic of

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

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

Headache Wellness Center; 🇺🇸 Greensboro, North Carolina, United States

Jefferson University Hospitals; 🇺🇸 Philadelphia, Pennsylvania, United States

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

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu Si, Gyeonggi-Do, Korea, Republic of

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States