← Back to Search

Monoclonal Antibodies

Erenumab for Pediatric Migraine (OASIS(EM) Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or subject self-report or parents' or legal representative's report.

Be younger than 18 years old

Must not have

History of cluster headache or hemiplegic migraine headache.

Use of prohibited medication within 1 month before the start of the baseline phase and/or during the baseline phase

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 12 of the double blind treatment phase

Awards & highlights

Pivotal Trial

Summary

This trial will test if erenumab is effective and safe in preventing migraines in children and adolescents. The hypothesis is that erenumab will reduce the number of monthly migraines days compared to placebo.

Who is the study for?

This trial is for children (6-11 years) and adolescents (12-17 years) with episodic migraines, occurring 4 to less than 15 days per month. Participants must have a history of migraine for at least one year and be able to follow the study's diary requirements. They can't join if they've had certain types of headaches, no response to more than two preventive medications, substance abuse issues, significant neurological disorders other than migraine, or are using excluded treatments.

What is being tested?

The trial tests different doses of Erenumab against a placebo in preventing migraines in young patients. The goal is to see if Erenumab reduces the number of monthly migraine days over three months compared to placebo. Patients will randomly receive one of three Erenumab doses or a placebo without knowing which one.

What are the potential side effects?

Erenumab may cause reactions like injection site pain or redness, constipation, muscle spasms or cramps. It might also lead to allergic reactions such as rash or itching. Since it's being tested in children and adolescents, close monitoring for any unusual side effects is crucial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had migraines for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of cluster or hemiplegic migraine headaches.

Select...

I haven't taken any prohibited medications in the last month.

Select...

I haven't used devices or procedures like acupuncture to prevent migraines in the last 3 months.

Select...

I have taken CGRP pathway medication in the last 4 months.

Select...

I am not currently in another drug study and it's been over 90 days since my last one.

Select...

My liver isn't working properly, shown by high bilirubin or ALT/AST levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 12 of the double blind treatment phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 12 of the double blind treatment phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 12 of the double blind treatment phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in MMDs

Secondary study objectives

Change from baseline in migraine-related disability and productivity

Change in MMDs from baseline to the average of the first 3 months

Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose level 2Experimental Treatment2 Interventions

Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.

Group II: Dose level 1Experimental Treatment2 Interventions

Group III: PlaceboPlacebo Group1 Intervention

Participants will be randomized to a placebo comparator.

0 / 7Eligibility criteria met