Trials / Completed
CompletedNCT03333109
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 900 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
Detailed description
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Erenumab | 70 mg/mL pre-filled syringe administered subcutaneously |
| OTHER | Placebo | Matching placebo in pre-filled syringe administered subcutaneously |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2020-01-13
- Completion
- 2020-01-13
- First posted
- 2017-11-06
- Last updated
- 2021-10-11
- Results posted
- 2021-03-09
Locations
81 sites across 11 countries: Argentina, India, Lebanon, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03333109. Inclusion in this directory is not an endorsement.