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Monoclonal Antibodies

AMG334 70 mg/140 mg for Migraine

Phase 4
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Study Summary

This trial is testing whether a new migraine medication is better than current oral medications. The new medication is given as a shot, and it is measured by how many people complete one year on the medication and have at least a 50% reduction in monthly migraine days.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52
Number of Participants Who Completed Initially Assigned Treatment at Month 12
Number of Responders as Measured by the Patient's Global Impression of Change (PGIC) Scale at Week 52

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AMG334 70 mg/140 mgExperimental Treatment2 Interventions
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.
Group II: Oral ProphylacticActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG334
2019
Completed Phase 4
~630
Oral Prophylactic
2019
Completed Phase 4
~630

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,067 Total Patients Enrolled
19 Trials studying Migraine
9,429 Patients Enrolled for Migraine
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,414 Total Patients Enrolled
5 Trials studying Migraine
886 Patients Enrolled for Migraine
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,530 Total Patients Enrolled
19 Trials studying Migraine
9,429 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients
2019. "Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03927144.
~105 spots leftby Apr 2025
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