Trials / Completed
CompletedNCT00156910
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 679 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a 60 week study including a double-blind phase followed by an open-label extension phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum Toxin Type A | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| OTHER | Placebo (saline) | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2007-11-01
- Completion
- 2008-07-01
- First posted
- 2005-09-12
- Last updated
- 2013-11-18
- Results posted
- 2010-12-07
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00156910. Inclusion in this directory is not an endorsement.