A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
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|ClinicalTrials.gov Identifier: NCT01516892|
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Biological: onabotulinumtoxinA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||716 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
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.
- Change From Baseline in the Frequency of Headache Days [ Time Frame: 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.
- Change From Baseline in the Frequency of Headache Days [ Time Frame: 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 [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516892
|Study Director:||Medical Director||Allergan|
|Other Study ID Numbers:||
The COMPEL Study ( Other Identifier: Allergan, Inc )
|First Posted:||January 25, 2012 Key Record Dates|
|Results First Posted:||January 6, 2017|
|Last Update Posted:||January 6, 2017|
|Last Verified:||November 2016|
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents