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BOTOX® Prophylaxis in Patients With Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01432379
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : December 12, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date September 9, 2011
First Posted Date September 13, 2011
Results First Submitted Date July 26, 2016
Results First Posted Date December 12, 2016
Last Update Posted Date January 8, 2019
Actual Study Start Date September 9, 2011
Actual Primary Completion Date May 12, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2016)
Incidence Rate of Dysphagia [ Time Frame: 64 weeks ]
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.
Original Primary Outcome Measures
 (submitted: September 12, 2011)
Incidence of Dysphagia [ Time Frame: 64 weeks ]
Change History Complete list of historical versions of study NCT01432379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 19, 2016)
Incidence Rate of Intractable Migraine [ Time Frame: 64 weeks ]
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.
Original Secondary Outcome Measures
 (submitted: September 12, 2011)
Incidence of Worsening or Intractable Migraine [ Time Frame: 64 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BOTOX® Prophylaxis in Patients With Chronic Migraine
Official Title Not Provided
Brief Summary This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Chronic Migraine
Condition Migraine Disorders
Intervention Biological: botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Other Name: BOTOX®
Study Groups/Cohorts botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Intervention: Biological: botulinum toxin Type A
Publications * Matharu M, Pascual J, Nilsson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 19, 2016)
1168
Original Estimated Enrollment
 (submitted: September 12, 2011)
300
Actual Study Completion Date May 12, 2015
Actual Primary Completion Date May 12, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of chronic migraine
  • Willing to use BOTOX® as preventative treatment for migraine

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01432379
Other Study ID Numbers 191622-110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date December 2018