NCT01952574

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

Detailed description

The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase (DBTP), an open-label treatment phase (OLTP) for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product \[IP\]). In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg. During the open-label treatment phase, participants were to receive erenumab 70 mg QM from week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016), participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264. The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up (16 weeks after the last dose of investigational product). During the OLTP participants enrolled at sites in the United States could enroll in an optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20 June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During the CHU substudy, participants initially self-administered IP under site supervision on substudy day 1, and then self-administered IP at home on substudy days 29 and 57.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Erenumab	Administered by study site staff once a month (QM) as a subcutaneous injection
DRUG	Placebo	Administered by study site staff once a month (QM) as a subcutaneous injection
DRUG	Erenumab PFS	Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
DRUG	Erenumab AI/Pen	Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy

Timeline

• Start date: 2013-08-06
• Primary completion: 2014-09-25
• Completion: 2019-11-12
• First posted: 2013-09-30
• Last updated: 2022-10-12
• Results posted: 2018-07-10

Locations

66 sites across 7 countries: United States, Canada, Denmark, Finland, Germany, Norway, Sweden