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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
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

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)
Primary Purpose: Treatment
Study Start Date : December 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BOTOX®
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.
Biological: onabotulinumtoxinA
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.
Other Names:
  • BOTOX®
  • botulinum toxin Type A




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
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

Information from the National Library of Medicine

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


  Show 32 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01516892     History of Changes
Other Study ID Numbers: GMA-BTX-CM-10-001
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

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents