A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines
Sponsor
Allergan (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01749423
Collaborator
(none)
0
13
Study Details
Study Description
Brief Summary
This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Study Start Date
:
Nov 1, 2012
Anticipated Primary Completion Date
:
Dec 1, 2013
Anticipated Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All participants Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective review of medical records. |
Biological: OnabotulinumtoxinA
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Headache Days [Up to 56 Weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
History of chronic migraines
-
15 or more headache days over a 30 day period
-
A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units
Exclusion Criteria:
- Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01749423
Other Study ID Numbers:
- GMA-BTX-CM-12-518
First Posted:
Dec 13, 2012
Last Update Posted:
Feb 3, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms: