A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 20, 2012
Last updated: April 17, 2014
Last verified: April 2014
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.
|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 60, Week 108 ] [ Designated as safety issue: No ]
|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)|
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516892
|United States, Illinois|
|Northbrook, Illinois, United States|
|Melbourne, Victoria, Australia|
|Korea, Republic of|
|Uljeongbu, Gyeonggido, Korea, Republic of|
Sponsors and Collaborators
|Study Director:||Medical Director||Allergan|