Erenumab for Migraine

(OASIS(CM) Trial)

Not currently recruiting at 110 trial locations

Overseen By Amgen Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Cluster headache, Hemiplegic migraine, No response to 3+ treatments, Suicidal behavior, Major psychiatric disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests erenumab, a treatment aimed at reducing migraine days in children and teens with chronic migraines. The goal is to determine if erenumab is safe and effective compared to a placebo (a treatment with no active drug) by assessing its impact on migraine days over three months. Participants will be grouped by body weight to receive different doses or a placebo. Children and teens aged 6 to under 18, with a history of migraines for at least a year and frequent migraine days, might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for migraines.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medication for anxiety or mild depression, you must be on a stable dose for at least 3 months before the trial starts.

Is there any evidence suggesting that erenumab is likely to be safe for children and adolescents?

Research has shown that erenumab is generally safe. In studies conducted over five years with 2,537 patients, it was well-tolerated by individuals with migraines. These studies covered 2,310 patient-years, providing detailed and reliable data. Most participants did not experience serious side effects, and erenumab has been safely used to prevent migraines in adults. This information may reassure regarding its safety for children and teenagers in the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Erenumab is unique because it targets the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine pathophysiology. Unlike traditional migraine treatments, such as triptans that work by constricting blood vessels, erenumab acts by blocking the receptor that CGRP binds to, preventing migraine attacks from starting. This novel mechanism offers a new approach and is particularly exciting for those who may not respond well to existing therapies. Researchers are hopeful that erenumab could provide a more effective and potentially more tolerable option for preventing migraines.

What evidence suggests that erenumab might be an effective treatment for chronic migraine in children and adolescents?

Research has shown that erenumab effectively reduces the number of migraine days each month for people with chronic migraines. About half of the patients using erenumab experienced at least a 50% reduction in migraine days, with some seeing a reduction of 75% or more. In this trial, participants will receive one of two doses of erenumab or a placebo at random. Patients also reported improvements in daily life and felt less impacted by headaches. These findings suggest that erenumab can significantly help manage chronic migraines. ^{6 7 8 9 10}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase)

Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Prospective Baseline

Participants undergo a 4-week baseline phase to establish migraine frequency

4 weeks

1 visit (in-person)

Double-blind Treatment Phase (DBTP)

Participants receive placebo or erenumab dose based on body weight via subcutaneous injection once a month

24 weeks for Group 1, 12 weeks for Group 2

Monthly visits (in-person)

Blinded Extension Phase

All participants receive erenumab dose based on body weight

40 weeks

Monthly visits (in-person)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Erenumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Dose Level 2 Experimental Treatment 2 Interventions

Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.

Group II: Dose Level 1 Experimental Treatment 2 Interventions

Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.

Group III: Placebo Placebo Group 1 Intervention

Erenumab is already approved in United States, European Union for the following indications:

Approved in United States as Aimovig for:

• Prevention of migraine in adults

Approved in European Union as Aimovig for:

• Prevention of migraine in adults

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Published Research Related to This Trial

Erenumab significantly reduced cumulative monthly migraine pain in both episodic (946 patients) and chronic migraine (656 patients) patients compared to placebo, indicating its efficacy in managing migraine pain intensity.

In episodic migraine patients, erenumab also led to a significant decrease in average monthly pain intensity, while this effect was not statistically significant in chronic migraine patients, suggesting a stronger benefit in episodic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. Lipton, RB., Dodick, DW., Kudrow, D., et al.[2022]

Erenumab, a monoclonal antibody for migraine prevention, has shown a strong safety and tolerability profile in various studies, with no severe adverse events reported and common side effects being mild, such as local skin reactions and constipation.

The review of multiple studies indicates that treatment with erenumab is well tolerated, with no significant issues leading to discontinuation, reinforcing its potential as a safe option for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability evaluation of erenumab for the preventive treatment of migraine. Deligianni, CI., Mitsikostas, DD., Ashina, M.[2021]

Erenumab (AIMOVIG™) is a monoclonal antibody that targets the CGRP receptor, which plays a key role in migraine development, and has shown significant effectiveness in reducing migraine frequency in phase II and III clinical trials.

Erenumab has been approved in the US for preventing migraines in adults with at least 4 migraine days per month, indicating its efficacy and safety for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erenumab: First Global Approval. Markham, A.[2019]

Aimovig (erenumab-aooe) is the first drug specifically developed for the prevention of migraines, marking a significant advancement in migraine treatment.

Its unique mechanism of action sets it apart from other migraine medications, potentially offering new hope for patients seeking effective prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aimovig for Migraine Prevention: The New Kid May Have Trouble Fitting in. Reinke, T.[2019]

A study involving 204 participants with migraine showed that over 90% found the erenumab autoinjector easy to use and felt confident in self-injecting, with an average satisfaction rating of over 4.5 on a 5-point scale.

The device was also well-received in terms of size and compactness, indicating that the design of the erenumab autoinjector is user-friendly and suitable for individuals new to self-injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine. Mead, J., Dammerman, R., Rasmussen, S.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8205467/

Long-term Efficacy and Safety of Erenumab

Endpoints included reduction of ≥50% in monthly migraine days (MMD) from DBTP baseline and change in MMD from DBTP baseline, Headache Impact Test score, and ...

2.

aimovighcp.com

aimovighcp.com/efficacy/pivotal-and-long-term-data

Pivotal and Long-Term Efficacy Data

~5 out of 10 Aimovig®-treated patients cut migraine days by at least 75% Consider open-label treatment phase study limitations when interpreting results. The ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02456740

Study to Evaluate the Efficacy and Safety of Erenumab ...

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days. Detailed ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33400330/

Long-term efficacy and safety of erenumab in migraine ...

Patient-reported outcomes indicated stable improvements in disability, headache impact, and migraine-specific quality of life. Exposure-adjusted patient ...

5.

aimovighcp.com

aimovighcp.com/efficacy/chronic-migraine-data

Chronic Migraine Data | Aimovig® (erenumab-aooe)

Find efficacy data for Aimovig® measuring monthly migraine days and prior prevention in patients with chronic migraine. See Full Prescribing & Safety Info.

6.

aimovighcp.com

aimovighcp.com/

Aimovig® (erenumab-aooe): Preventive Migraine Treatment

Learn about Aimovig®, an anti-CGRP inhibitor injection, for the preventive treatment of migraine in adult patients. See Full Prescribing & Safety Info.

7.

aimovighcp.com

aimovighcp.com/safety/pivotal-and-long-term-data

Pivotal and Long-term Safety | Aimovig® (erenumab-aooe)

Consistent safety profile established year-over-year for 5 years. Phase 2 Episodic Migraine Open-Label Treatment Phase (OLTP) Safety Data—Through 5 Years1.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6779015/

Long-term safety and tolerability of erenumab: Three-plus year ...

Across four registrational studies, the safety of erenumab has been evaluated in 2537 patients with migraine, representing 2310 patient-years of exposure (11).

9.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2787208

Assessment of Erenumab Safety and Efficacy in Patients ...

Findings of this analysis suggest that erenumab may be safe and effective for patients with migraine with and without history of aura.

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01952574

NCT01952574 | Study to Evaluate the Efficacy and Safety ...

Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase; Headache frequency: < 15 headache ...