Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine (OASIS (EM))
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| ClinicalTrials.gov Identifier: NCT03836040 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2019
Last Update Posted : February 5, 2021
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Sponsor:
Amgen
Collaborator:
Novartis
Information provided by (Responsible Party):
Amgen
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Brief Summary:
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric subjects with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine | Drug: Erenumab Dose 1 Drug: Erenumab Dose 2 Drug: Erenumab Dose 3 Other: Placebo | Phase 3 |
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine.
The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the double-blind treatment phase (24 weeks) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug).
The study intends to enroll 456 participants (376 adolescents and up to 80 children).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 456 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM]) |
| Actual Study Start Date : | July 19, 2019 |
| Estimated Primary Completion Date : | August 14, 2024 |
| Estimated Study Completion Date : | December 14, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Migraine
MedlinePlus related topics:
Migraine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose level 1
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
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Drug: Erenumab Dose 1
Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Other Names:
Drug: Erenumab Dose 2 Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Other Names:
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Experimental: Dose level 2
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
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Drug: Erenumab Dose 2
Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Other Names:
Drug: Erenumab Dose 3 Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Other Names:
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| Placebo Comparator: Placebo |
Other: Placebo
Placebo matching dose for erenumab dose 1, 2 and 3. |
Primary Outcome Measures :
- Change from baseline in monthly migraine days (MMDs) [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
Secondary Outcome Measures :
- Change in monthly headache days from baseline [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
- Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
- Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the double-blind treatment period (DBTP).
- Change in monthly migraine days (MMDs) from baseline to the average of the first 6 month [ Time Frame: Completion of double blind treatment phase at 24 weeks ]To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).
- Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale) [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP). This will be measured in a daily electronic diary (eDiary) with a visual analogue scale.
- Change from baseline in migraine-related disability and productivity [ Time Frame: Completion of double blind treatment phase at 12 weeks ]To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) to month 3 of the double-blind treatment period (DBTP).
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| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) ICHD-3 specifications for pediatric migraine (subjects aged less than 18 years), should be considered for the diagnosis of migraine
- History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening.
- Migraine frequency: greater than or equal to 4 and less than 15 migraine days during the baseline phase based on the eDiary calculations.
- Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations.
- Demonstrated at least 80% compliance with the eDiary (eg, completing eDiary items for at least 23 out of 28 days during the baseline phase).
Key Exclusion Criteria:
- History of cluster headache or hemiplegic migraine headache.
- No therapeutic response with greater than 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.
No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- History of major psychiatric disorder. Subjects with anxiety disorder and/or mild major depressive disorder (with PHQ-A score 9) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836040
Contacts
| Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
Locations
Show 60 study locations
Sponsors and Collaborators
Amgen
Novartis
Investigators
| Study Director: | MD | Amgen |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT03836040 |
| Other Study ID Numbers: |
20150125 2017-002397-39 ( EudraCT Number ) |
| First Posted: | February 11, 2019 Key Record Dates |
| Last Update Posted: | February 5, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
| Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below. |
| URL: | https://www.amgen.com/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amgen:
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Migraine Headache Prevention Pediatric Episodic Migraine |
Additional relevant MeSH terms:
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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Erenumab Antibodies, Monoclonal |
Calcitonin Gene-Related Peptide Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Immunologic Factors |