Clinical Trial: A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed Prophyl

Brief Summary: The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have unsuccessfully failed other preventive migraine treatments.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Percentage of patients with a 50% response in the reduction of Monthly Migraine Days (MMD) [ Time Frame: The last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]

Assessed via patient report collected in the headache e-diary.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in the number of monthly migraine days (MMDs) from baseline to month 3 [ Time Frame: Baseline, the last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Change in the Migraine Physical Function Impact Diary (MPFID) "impact on everyday activities" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the MPFID "physical impairment" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the number of monthly acute migraine-specific medication treatment days [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Percentage of patients with a 75% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.
  • Percentage of patients with a 100% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 17, 2017
Date Started: March 20, 2017
Date Completion: March 22, 2019
Last Updated: April 20, 2017
Last Verified: April 2017