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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 below

Select...

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

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

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 more

OASIS(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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,382 Previous Clinical Trials

1,379,227 Total Patients Enrolled

18 Trials studying Migraine

8,973 Patients Enrolled for Migraine

NovartisIndustry Sponsor

1,613 Previous Clinical Trials

2,720,803 Total Patients Enrolled

4 Trials studying Migraine

430 Patients Enrolled for Migraine

MDStudy DirectorAmgen

928 Previous Clinical Trials

926,274 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do people of all ages qualify for this clinical trial, or are there age restrictions?

"According to the inclusion criteria, the patients that this study are looking for must be between 6 to 17 years old. Out of the total 165 clinical trials, this study makes up for 34 studies for people under the age of 18."

Answered by AI

Are there many research facilities conducting this trial within the US?

"iResearch Savannah, LLC, Marshfield Clinic, and Premiere Research Institute are a few of the 25 locations where this study is taking place."

Answered by AI

Can patients sign up for this experiment right now?

"That is correct, the listing on clinicaltrials.gov currently shows that this study is seeking participants. The trial was first posted on July 19th, 2019 and was most recently edited on October 19th, 2022. The trial needs to enroll 456 patients from 25 different sites."

Answered by AI

What other similar trials exist for this treatment?

"Since 2019, Erenumab Dose 3 has been the subject of global medical research. The first trial was completed in that year and was sponsored by Novartis. After 456 patients were studied, Erenumab Dose 3 received Phase 3 drug approval. Today, there are 18 active studies involving this medication taking place in 178 cities and 32 countries."

Answered by AI

What is the latest on Erenumab Dose 3's FDA approval process?

"Erenumab Dose 3 received a safety rating of 3. This is based on it being a Phase 3 trial, which has both efficacy and multiple rounds of safety data."

Answered by AI

Are there similar cases to Erenumab Dose 3?

"Erenumab Dose 3 was first trialled in 2019 at Childrens Hospital of Philadelphia. Out of the 18252 completed clinical trials, 18 are currently active with a large number taking place in Savannah, Georgia."

Answered by AI

How can I sign up for the trial?

"This trial is looking for 456 participants, between the ages of 6 and 17, who have migraine. The following criteria must also be met: Attacks may last 2 to 72 hours., Migraine headache is more often bilateral than in adults; unilateral pain usually emerges in late adolescence or early adult life., Migraine headache is usually frontotemporal. Occipital headache in children is rare and calls for diagnostic caution., A subset of otherwise typical subjects have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these subjects form a separate subgroup of migraine subjects., In young"

Answered by AI

How many study participants are receiving treatment?

"In order to complete this clinical trial, 456 patients that meet the inclusion criteria will be recruited. The sponsor, Novartis, plans to run the trial out of multiple sites including iResearch Savannah, LLC in Savannah, Georgia and Marshfield Clinic in Marshfield, Wisconsin."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine

2019. "Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836040.

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