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

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516892
• Other study ID #: GMA-BTX-CM-10-001
• Secondary ID: The COMPEL Study
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2012
• Last updated: January 11, 2016
• Start date: December 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Biological:
• onabotulinumtoxinA
Patients will receive 155 U of onabotulinumtoxinA approximately every 12 weeks for 96 weeks. OnabotulinumtoxinA will be administered as 31 intramuscular injections in 7 head/neck muscle areas.

Locations

Country	Name	City	State
Australia	Dr. Joseph Frasca	Adelaide
Australia	Dr. Con Yiannikas	Burwood
Australia	Associate Professor Richard Stark	Melbourne
Australia	Richmmond Neurology	Richmond
Australia	Associate Professor John O'Sullivan	Spring Hill
Korea, Republic of	Hallym University Sacred Heart Hospital	Dongan-gu, Anyang	Anyang Gyeonggi-do
Korea, Republic of	Kangbuk Samsung Hospital	Jongno-Gu	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Jongno-Gu	Seoul
Korea, Republic of	Seoul Eulji Hospital	Nowon-Gu	Seoul
Korea, Republic of	Yonsei University Dental Hospital	Seodaemum-Gu	Seoul
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu Si	Gyeonggi-Do
United States	Dent Neurologic Institute	Amherst	New York
United States	Mid-Atlantic Headache Institute	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Ohio Clinical Research Partners, LLC	Canton	Ohio
United States	Wesley Headache Clinic	Cordova	Tennessee
United States	Baylor Research Institute	Dallas	Texas
United States	The Research Center of Southern California, LLC	Encinitas	California
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Kaiser Permanente Research Office/Neurology Department	Largo	Maryland
United States	USC Neurology	Los Angeles	California
United States	Robbins Headache Clinic	Northbrook	Illinois
United States	Jefferson University Hospitals	Philadelphia	Pennsylvania
United States	Renown Institute for Neurosciences	Reno	Nevada
United States	UCSF Headache Center	San Francisco	California
United States	Neurological Research Institute	Santa Monica	California
United States	Arizona Neurological Institute	Scottsdale	Arizona
United States	Clinvest Research	Springfield	Missouri
United States	Mercy Health Research	St. Louis	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Frequency of Headache Days		Baseline, Week 108	No
Secondary	Change from Baseline in the Frequency of Headache Days		Baseline, Week 60	No
Secondary	Change from Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score		Baseline, Week 60, Week 108	No