Erenumab for Migraine

(OASIS(CM) Trial)

Recruiting at 89 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

284 Participants Needed

Trial Summary

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 erenumab safe for humans?

Erenumab is generally safe for humans, with the most common side effects being local skin reactions and constipation. No severe side effects or frequent issues leading to stopping the treatment were found, and it is well tolerated. ^{1 2 3 4 5}

How is the drug erenumab unique for treating migraines?

Erenumab is unique because it is the first drug specifically developed for migraine prevention, working by blocking the CGRP receptor, which is involved in migraine development. It is administered once a month using a prefilled autoinjector, making it convenient for patients to use at home. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability evaluation of erenumab for the preventive treatment of migraine. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Erenumab: First Global Approval. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Clinic and genetic predictors in response to erenumab. [2022]