Your session is about to expire
← Back to Search
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 belowSelect...
I am a child or teenager who can agree to join the study.
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
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child or teenager who can agree to join the study.I have had continuous migraine pain without any pain-free periods for the last month.I have a stable, mild psychiatric condition and take no more than 1 medication for it.I've tried more than 3 types of migraine prevention medications without success.I have a history of cluster or hemiplegic migraine headaches.You have a history of trying to hurt yourself or others, or you might be at risk of doing so.
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.
Share this study with friends
Copy Link
Messenger