Clinical Trial: A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
Brief Summary: The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome:
- Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]
- Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: June 9, 2016
Date Started: July 2016
Date Completion: August 2020
Last Updated: May 11, 2017
Last Verified: May 2017
