Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
CompletedPhase 2NCT03238781
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
Study details
- Official title
- A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
- Conditions
- Chronic Migraine or Episodic Migraine
- Interventions
- Drug: Placebo
- Drug: AMG 301
- Sponsor
- Amgen
- Start date
- 2017-09-06
- Primary completion
- 2018-10-16
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Austria, Canada, Czechia, Denmark, Finland, Germany, Sweden, United States
- Total sites listed
- 49
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form. * History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013) * Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening. * Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy Exclusion Criteria: * Older than 50 years of age at migraine onset. * History of cluster headache, hemiplegic migraine headache. * Unable to differentiate migraine from other headaches. * Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Canadian sites (6)
| Facility | City | Province |
|---|---|---|
| Research Site | Calgary | Alberta |
| Research Site | Surrey | British Columbia |
| Research Site | Markham | Ontario |
| Research Site | Toronto | Ontario |
| Research Site | Lévis | Quebec |
| Research Site | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03238781