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

This study is currently recruiting participants.
Verified May 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01516892
First received: January 20, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Migraine Disorders
 Biological: onabotulinumtoxinA
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 108 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 60 ] [ Designated as safety issue: No ]
  • Change from Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score [ Time Frame: Baseline, Week 108 ] [ Designated as safety issue: No ]
  • Change from Baseline in HIT-6 Total Score [ Time Frame: Baseline, Week 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX®
Patients will receive 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 96 weeks. OnabotulinumtoxinA will be administered as 31 intramuscular injections in 7 head/neck muscle areas.
 Biological: onabotulinumtoxinA
Patients will receive 155 U of onabotulinumtoxinA approximately every 12 weeks for 96 weeks. OnabotulinumtoxinA will be administered as 31 intramuscular injections in 7 head/neck muscle areas.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516892

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, Illinois
Recruiting
Northbrook, Illinois, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01516892     History of Changes
Other Study ID Numbers: GMA-BTX-CM-10-001, The COMPEL Study
Study First Received: January 20, 2012
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013