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Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

NCT03238781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2020-02-07

Study results available
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Summary

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.

Conditions

  • Chronic Migraine or Episodic Migraine

Interventions

DRUG

Placebo

Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.

DRUG

AMG 301

AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-10-16
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238781 on ClinicalTrials.gov