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Monoclonal Antibodies

Erenumab for Migraine (OASIS(CM) 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
Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study
Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of double blind treatment phase at 24 weeks
Awards & highlights

OASIS(CM) Trial Summary

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

Who is the study for?
This trial is for children (6-11 years) and adolescents (12-17 years) with chronic migraine. Participants must have shown good compliance with an eDiary during the baseline period. They can't join if they have major psychiatric disorders, certain types of migraines like cluster or hemiplegic, continuous pain without breaks, a history of suicidal behavior, or no response to more than three previous migraine prevention medications.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of different doses of Erenumab against a placebo in preventing migraines in young patients. It aims to see if Erenumab reduces monthly migraine days over a 3-month period compared to those taking a non-active treatment.See study design
What are the potential side effects?
While not specified here, common side effects from similar trials may include injection site reactions such as pain or swelling, constipation, muscle cramps or spasms, and possibly allergic reactions.

OASIS(CM) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a child or teenager who can agree to join the study.

OASIS(CM) Trial 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

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(CM) 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

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,609 Previous Clinical Trials
2,717,640 Total Patients Enrolled
4 Trials studying Migraine
600 Patients Enrolled for Migraine
AmgenLead Sponsor
1,362 Previous Clinical Trials
1,384,985 Total Patients Enrolled
18 Trials studying Migraine
9,142 Patients Enrolled for Migraine
MDStudy DirectorAmgen
904 Previous Clinical Trials
922,480 Total Patients Enrolled
18 Trials studying Migraine
9,142 Patients Enrolled for Migraine

Media Library

Erenumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03832998 — Phase 3
Migraine Research Study Groups: Dose Level 1, Dose Level 2, Placebo
Migraine Clinical Trial 2023: Erenumab Highlights & Side Effects. Trial Name: NCT03832998 — Phase 3
Erenumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832998 — Phase 3

Frequently Asked Questions

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

Does this research encompass patients that are elderly?

"This clinical trial is recruiting participants who are aged 6 to 17 years old."

Answered by AI

Who would fit the requirements to take part in this clinical trial?

"This trial is looking for 286 participants aged 6-17 who suffer from migraines. The ideal candidate should have a history of migraines (with or without aura) for at least 12 months before screening, according to the IHS Classification ICHD-3. In addition, the candidate should have demonstrated at least 80% compliance with an eDiary over the last 28 days of the baseline period, if more than 28 days in duration. Headache frequency should also be greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days"

Answered by AI

Are Canadian medical facilities participating in this trial?

"Patients are being recruited from Josephson Wallack Munshower Neurology in Indianapolis, Indiana, Preferred Primary Care Physicians, Inc in Pittsburgh, Pennsylvania, Childrens Mercy Hospital and Clinics in Kansas City, Missouri, and 24 other locations."

Answered by AI

Are there any other similar studies to this one?

"As of now, 18 different international trials for Erenumab Dose 3 are ongoing in 178 cities and 32 countries. The first trial was sponsored by Novartis in 2019. That particular trial reached Phase 3 approval and involved 456 patients. In the two years since the Novartis study, 18252 more trials have been completed."

Answered by AI

Are there any other trials that have included Erenumab Dose 3?

"As of right now, there are 18 different clinical trials being conducted for Erenumab Dose 3. Three of those trials are in Phase 3. Even though the majority of the trials for this treatment are based in Scottsdale, Arizona, 547 different locations are running studies."

Answered by AI

Is Erenumab Dose 3 safe for human consumption?

"Erenumab Dose 3 is considered safe by our team at Power. This is a Phase 3 trial, which means that there is not only data supporting efficacy, but also multiple rounds of data supporting safety."

Answered by AI
~92 spots leftby Jun 2026