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.
Brief Title
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine Disorders
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
* Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01516892
Org Class
Industry
Org Full Name
Allergan
Org Study Id
GMA-BTX-CM-10-001
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Primary Outcomes
Outcome 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.
Outcome Measure
Change From Baseline in the Frequency of Headache Days
Outcome Time Frame
Baseline, Week 108
Secondary Ids
Secondary Id
The COMPEL Study
Secondary Outcomes
Outcome 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.
Outcome Time Frame
Baseline, Week 60
Outcome Measure
Change From Baseline in the Frequency of Headache Days
Outcome 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.
Outcome Time Frame
Baseline, Week 60, Week 108
Outcome Measure
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kathleen Mullin
Investigator Email
kmullin@montefiore.org
Investigator Phone
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- MIGRAINE DISORDERS
Headaches & Migraine --- MIGRAINE DISORDERS
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS, PRIMARY
Headaches & Migraine --- HEADACHE DISORDERS, PRIMARY
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS
Headaches & Migraine --- HEADACHE DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
MeSH Terms
MIGRAINE DISORDERS
HEADACHE DISORDERS, PRIMARY
HEADACHE DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
BOTULINUM TOXINS, TYPE A
BOTULINUM TOXINS
METALLOENDOPEPTIDASES
ENDOPEPTIDASES
PEPTIDE HYDROLASES
HYDROLASES
ENZYMES
ENZYMES AND COENZYMES
METALLOPROTEASES
BACTERIAL PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
BACTERIAL TOXINS
TOXINS, BIOLOGICAL
BIOLOGICAL FACTORS