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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
onabotulinumtoxinA
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Neurological Institute
  • The Research Center of Southern California, LLC
  • USC Neurology
  • UCSF Headache Center
  • Neurological Research Institute
  • Advanced Neurosciences Research, LLC
  • Tampa General Hospital
  • Premiere Research Institute at Palm Beach Neurology
  • Robbins Headache Clinic
  • Mid-Atlantic Headache Institute
  • Kaiser Permanente Research Office/Neurology Department
  • Clinvest Research
  • Mercy Health Research
  • Renown Institute for Neurosciences
  • Dent Neurologic Institute
  • Montefiore Medical Center
  • Headache Wellness Center
  • Ohio Clinical Research Partners, LLC
  • Jefferson University Hospitals
  • Wesley Headache Clinic
  • Baylor Research Institute
  • Dr. Joseph Frasca
  • Dr. Con Yiannikas
  • Associate Professor Richard Stark
  • Richmmond Neurology
  • Associate Professor John O'Sullivan
  • Hallym University Sacred Heart Hospital
  • Uijeongbu St. Mary's Hospital
  • Kangbuk Samsung Hospital
  • Seoul St. Mary's Hospital
  • Seoul Eulji Hospital
  • Yonsei University Dental Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BOTOX®

Arm 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.

Outcomes

Primary Outcome Measures

Change From Baseline in the Frequency of Headache Days
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

Change From Baseline in the Frequency of Headache Days
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
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.

Full Information

First Posted
January 20, 2012
Last Updated
November 9, 2016
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01516892
Brief Title
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
716 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOTOX®
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Primary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Headache Days
Description
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.
Time Frame
Baseline, Week 108
Secondary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Headache Days
Description
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.
Time Frame
Baseline, Week 60
Title
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Description
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.
Time Frame
Baseline, Week 60, Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Neurological Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255-7450
Country
United States
Facility Name
The Research Center of Southern California, LLC
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
USC Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF Headache Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Robbins Headache Clinic
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Mid-Atlantic Headache Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Kaiser Permanente Research Office/Neurology Department
City
Largo
State/Province
Maryland
ZIP/Postal Code
20774
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-6988
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Renown Institute for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Ohio Clinical Research Partners, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Jefferson University Hospitals
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Wesley Headache Clinic
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dr. Joseph Frasca
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Dr. Con Yiannikas
City
Burwood
ZIP/Postal Code
NSW 2134
Country
Australia
Facility Name
Associate Professor Richard Stark
City
Melbourne
ZIP/Postal Code
VIC 3000
Country
Australia
Facility Name
Richmmond Neurology
City
Richmond
ZIP/Postal Code
VIC 3051
Country
Australia
Facility Name
Associate Professor John O'Sullivan
City
Spring Hill
ZIP/Postal Code
QLD 4000
Country
Australia
Facility Name
Hallym University Sacred Heart Hospital
City
Dongan-gu, Anyang
State/Province
Anyang Gyeonggi-do
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary's Hospital
City
Uijeongbu Si
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Jongno-Gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Jongno-Gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Seoul Eulji Hospital
City
Nowon-Gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Dental Hospital
City
Seodaemum-Gu
State/Province
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30630956
Citation
Blumenfeld AM, Tepper SJ, Robbins LD, Manack Adams A, Buse DC, Orejudos A, D Silberstein S. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):353-360. doi: 10.1136/jnnp-2018-319290. Epub 2019 Jan 10.
Results Reference
derived
PubMed Identifier
29404713
Citation
Blumenfeld AM, Stark RJ, Freeman MC, Orejudos A, Manack Adams A. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018 Feb 5;19(1):13. doi: 10.1186/s10194-018-0840-8.
Results Reference
derived
PubMed Identifier
26133547
Citation
Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015 Jul 3;15:100. doi: 10.1186/s12883-015-0353-x.
Results Reference
derived

Learn more about this trial

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

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