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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

Summary

This trial tests if erenumab, an injection given regularly, can reduce migraine days in children and adolescents with chronic migraines by blocking a protein that triggers these headaches. Erenumab has been shown to reduce migraine days and improve quality of life in adults with chronic and episodic migraines.

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.
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.
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.

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.

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Migraine treatments work through various mechanisms to alleviate symptoms and prevent recurrence. Erenumab, a CGRP receptor antagonist, blocks the activity of CGRP, a molecule involved in migraine pathophysiology, thereby reducing the frequency and severity of migraine attacks. Triptans, another common treatment, activate serotonin receptors to constrict blood vessels and inhibit pain pathways. Over-the-counter analgesics like acetaminophen and NSAIDs reduce inflammation and pain. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on individual needs and medical history, improving overall migraine management.
Efficacy of calcitonin gene-related peptide (CGRP) receptor blockers in reducing the number of monthly migraine headache days (MHDs): A network meta-analysis of randomized controlled trials.

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,629 Previous Clinical Trials
2,726,345 Total Patients Enrolled
4 Trials studying Migraine
600 Patients Enrolled for Migraine
AmgenLead Sponsor
1,427 Previous Clinical Trials
1,384,449 Total Patients Enrolled
18 Trials studying Migraine
9,143 Patients Enrolled for Migraine
MDStudy DirectorAmgen
967 Previous Clinical Trials
928,777 Total Patients Enrolled
18 Trials studying Migraine
9,143 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
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