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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 completion of double blind treatment phase at 24 weeks
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
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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:
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I have a history of cluster or hemiplegic migraine headaches.
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I haven't taken any prohibited medications in the last month.
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I haven't used devices or procedures like acupuncture to prevent migraines in the last 3 months.
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I have taken CGRP pathway medication in the last 4 months.
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I am not currently in another drug study and it's been over 90 days since my last one.
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My liver isn't working properly, shown by high bilirubin or ALT/AST levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of double blind treatment phase at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of double blind treatment phase at 24 weeks 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 monthly migraine days (MMDs)
Secondary study objectives
Change from baseline in migraine-related disability and productivity
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Change in monthly headache days from baseline
+3 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
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Group II: Dose level 1Experimental Treatment2 Interventions
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Group III: PlaceboPlacebo Group1 Intervention
Subjects will be randomized to a placebo comparator.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,434 Previous Clinical Trials
1,395,380 Total Patients Enrolled
18 Trials studying Migraine
8,973 Patients Enrolled for Migraine
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,151 Total Patients Enrolled
4 Trials studying Migraine
430 Patients Enrolled for Migraine
MDStudy DirectorAmgen
972 Previous Clinical Trials
939,552 Total Patients Enrolled
18 Trials studying Migraine
8,973 Patients Enrolled for Migraine

Media Library

Erenumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03836040 — Phase 3
Migraine Research Study Groups: Dose level 1, Dose level 2, Placebo
Migraine Clinical Trial 2023: Erenumab Highlights & Side Effects. Trial Name: NCT03836040 — Phase 3
Erenumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836040 — Phase 3
~100 spots leftby Jun 2026
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