Chronic Migraine, Headaches Clinical Trial
| Verified date | August 2015 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 15 or more headache days over a 30 day period - A minimum of 7 treatment cycles with onabotulinumtoxinA Exclusion Criteria: - Any treatment cycle dose of onabotulinumtoxinA greater than 200 units |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in the Number of Headache Days | The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks. | Treatment Cycle 7 (approximately 1.5 years) | No |