Clinical Trial: A Multicenter Assessment of ALD403 in Chronic Migraine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With
Brief Summary: The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
Detailed Summary:
Sponsor: Alder Biopharmaceuticals, Inc.
Current Primary Outcome: Change in migraine days from baseline to week 12. [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluate safety of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 49 weeks ]
- Cmax - Peak plasma concentration of ALD403 [ Time Frame: 49 weeks ]
- Tmax - Time to achieve peak plasma concentration of ALD403 [ Time Frame: 49 weeks ]
- AUC - Area under the plasma concentration vs.time curve of ALD403 [ Time Frame: 49 weeks ]
Original Secondary Outcome: Same as current
Information By: Alder Biopharmaceuticals, Inc.
Dates:
Date Received: October 20, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 17, 2017
Last Verified: May 2016
