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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of double blind treatment phase at 24 weeks
Awards & highlights
OASIS(EM) 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.Check my eligibility
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.See study design
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.
OASIS(EM) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had migraines for at least 12 months.
OASIS(EM) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of double blind treatment phase at 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of double blind treatment phase at 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in monthly migraine days (MMDs)
Secondary outcome measures
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 moreOASIS(EM) 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.
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Who is running the clinical trial?
AmgenLead Sponsor
1,383 Previous Clinical Trials
1,379,465 Total Patients Enrolled
18 Trials studying Migraine
8,973 Patients Enrolled for Migraine
NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,720,896 Total Patients Enrolled
4 Trials studying Migraine
430 Patients Enrolled for Migraine
MDStudy DirectorAmgen
929 Previous Clinical Trials
926,512 Total Patients Enrolled
18 Trials studying Migraine
8,973 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental health condition like schizophrenia, bipolar disorder, or severe depression.I have not received botulinum toxin in my head or neck in the last 4 months.I have taken CGRP pathway medication in the last 4 months.My liver isn't working properly, shown by high bilirubin or ALT/AST levels.I am not willing to use birth control during and for 16 weeks after treatment.I have had migraines for at least 12 months.I haven't taken any prohibited medications in the last month.I have had 4 to 14 migraines in the last month.I haven't responded to treatments from more than 2 categories for preventing migraines.I've had fewer than 15 headaches in the last month.I have a history of seizures or significant neurological issues, excluding childhood febrile seizures.I am not pregnant, breastfeeding, or planning to become pregnant within 16 weeks after the study ends.I am a child or teenager who can agree to join the study.I have a history of cluster or hemiplegic migraine headaches.I am not currently in another drug study and it's been over 90 days since my last one.I haven't used devices or procedures like acupuncture to prevent migraines in the last 3 months.I have not abused drugs or alcohol in the last year.You have a history of being infected with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Dose level 1
- Group 2: Dose level 2
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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