Trials / Completed
CompletedNCT02066415
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 667 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.
Detailed description
This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy. Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Erenumab | Administered once a month subcutaneously by authorized investigational site study staff. |
| DRUG | Placebo | Administered once a month subcutaneously by authorized investigational site study staff. |
Timeline
- Start date
- 2014-03-05
- Primary completion
- 2016-02-24
- Completion
- 2016-04-28
- First posted
- 2014-02-19
- Last updated
- 2022-10-12
- Results posted
- 2018-06-21
Locations
74 sites across 10 countries: United States, Canada, Czechia, Denmark, Finland, Germany, Norway, Poland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02066415. Inclusion in this directory is not an endorsement.