A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients
Overview
- Phase
- Phase 4
- Intervention
- AMG334
- Conditions
- Episodic Migraine
- Sponsor
- Amgen
- Enrollment
- 621
- Locations
- 112
- Primary Endpoint
- Number of Participants Who Completed Initially Assigned Treatment and Achieved at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is performed.
- •Adults greater than or equal to 18 years of age upon entry into screening.
- •Documented history of migraine (with or without aura) greater than or equal to 12 months prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
- •Greater than or equal to 4 and less than 15 days per month of migraine symptoms (based on ICHD-3 criteria) on average across 3 months prior to screening based on retrospective reporting.
- •Less than 15 days per month of headache symptoms (i.e., migraine and non-migraine).
- •Subjects in need for switching by documented failure of 1 or 2 prophylactic treatments in the last 6 months due to either lack of efficacy or poor tolerability. For subjects with 1 prior treatment failure, the failure should have occurred in the last 6 months. For subjects with 2 prior treatment failures, the second treatment failure should have occurred in the last 6 months.
- •During baseline: Confirmed migraine frequency of 4 to 14 migraine days and less than 15 days of headache symptoms.
- •During baseline: greater than or equal to 80% compliance with the headache diary.
Exclusion Criteria
- •Subjects meeting any of the following criteria are not eligible for inclusion in this study.
- •Older than 50 years of age at migraine onset.
- •History of cluster headache or hemiplegic migraine headache.
- •Unable to differentiate migraine from other headaches.
- •Lack of efficacy or poor tolerability with greater than 2 treatments from the 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.
- •Efficacy failure is defined as no meaningful reduction in headache frequency, duration, and/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.
- •Tolerability failure is defined as documented discontinuation due to adverse events of the respective medication during the last 6 months prior to screening.
- •The following scenarios do not constitute lack of therapeutic response:
- •Lack of sustained response to a medication.
- •Patient decision to halt treatment due to improvement.
Arms & Interventions
AMG334 70 mg/140 mg
Participants were randomized to receive 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Intervention: AMG334
AMG334 70 mg/140 mg
Participants were randomized to receive 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Intervention: Oral Prophylactic
Oral Prophylactic
Participants were randomized to receive a standard of care (SOC) locally approved oral prophylactic migraine medication once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Intervention: AMG334
Oral Prophylactic
Participants were randomized to receive a standard of care (SOC) locally approved oral prophylactic migraine medication once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Intervention: Oral Prophylactic
Outcomes
Primary Outcomes
Number of Participants Who Completed Initially Assigned Treatment and Achieved at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 12
Time Frame: Baseline and Month 12
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia If the participant took a migraine-specific medication (ie, triptan or ergotamine) during aura, or to treat a headache on a calendar day, then it was counted as a migraine day regardless of the duration and pain features/associated symptoms. In addition to achieving at least a 50% reduction from baseline in monthly migraine days, participants must have also completed their initially assigned treatment through Month 12.
Secondary Outcomes
- Number of Participants Who Completed Initially Assigned Treatment at Month 12(Month 12)
- Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52(Baseline and Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, and Week 52)
- Number of Responders as Measured by the Patient's Global Impression of Change (PGIC) Scale at Week 52(Baseline and Week 52)