Phase 4
Completed N=716
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT01516892 ↗
Enrolled (actual)
716
Serious AEs
10.5%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in the Frequency of Headache Days — 22.0; -10.7 headache days
◆ Published Evidence
Highly cited
193citations · ~24 / year
Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study.
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.
Linked Publications (4)
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Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study.
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Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety.
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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.
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OnabotulinumtoxinA treatment among diverse racial groups: Post hoc analysis of the phase 4 Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Frequency of Headache Days |
22.0; -9.2 | — |
| SECONDARY Change From Baseline in the Frequency of Headache Days |
22.0; -9.2 | — |
| SECONDARY Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score |
64.7; -6.8; -7.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01516892) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.