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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01516892
First received: January 20, 2012
Last updated: October 9, 2014
Last verified: October 2014
  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:


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 60, Week 108 ] [ Designated as safety issue: No ]

Enrollment: 713
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516892

Locations
United States, Illinois
Northbrook, Illinois, United States
Australia, Victoria
Melbourne, Victoria, Australia
Korea, Republic of
Uljeongbu, Gyeonggido, Korea, Republic of
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: October 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014