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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

January 20, 2012
May 9, 2013
December 2011
March 2016   (final data collection date for primary outcome measure)
Change from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 108 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516892 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Not Provided

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Migraine Disorders
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
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.
Intervention: Biological: onabotulinumtoxinA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Allergan Inc. clinicaltrials@allergan.com
United States
 
NCT01516892
GMA-BTX-CM-10-001, The COMPEL Study
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP