A Study to Evaluate the Efficacy and Sa… | Clinical Trial

Key information

Conditions

Treatment for Prevention of Chronic Migraine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Calgary, Alberta, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
Demonstrated at least 80% compliance with the eDiary.

Exclusion criteria

History of cluster headache or hemiplegic migraine headache
Unable to differentiate migraine from other headaches
Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
Received botulinum toxinin head or neck region within 4 months prior to screening.
Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

Treatment and study plan

Erenumab

Biological

Administered once a month subcutaneously by authorized investigational site study staff.

Other names: AMG 334, Aimovig™

Placebo

Drug

Administered once a month subcutaneously by authorized investigational site study staff.

Primary outcomes

Change From Baseline in Monthly Migraine Days

Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.

The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week treatment phase - the number of migraine days during the 4-week baseline phase.

Secondary outcomes

Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline

Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of treatment.

At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days

Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.
Change From Baseline in Cumulative Monthly Headache Hours

Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.

A qualified headache was defined as follows:
- a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or
- a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or
- a headache of any duration for which acute headache treatment was administered.
Number of Participants With Adverse Events

Time frame: From the first dose of study drug up to 16 weeks after the last dose (24 weeks)

Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:

Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
Number of Participants Who Developed Antibodies to Erenumab

Time frame: Baseline and weeks 2, 4, 8, 12 and 24

Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).

Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.

If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Feb 19, 2014
Registry last updated: Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

NCT02174861