A Study in Patients with Chronic Cluster Headache

Phase 1

• Conditions: Chronic Cluster Headache; MedDRA version: 19.0 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005429-11-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 162

Inclusion Criteria

• Participants (or patients) with a history of chronic cluster headache occuring without a remission period, or with remissions lasting less than 1 month for at least 1 year.

• Participants (or patients) are able to distinguish cluster headache
attacks from other headaches.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Current enrollment in or discontinuation within the last 30 days from, a
clinical trial involving any investigational drug or device.
• Current use or any prior exposure to any CGRP antibody, any antibody
to the CGRP receptor, or antibody to nerve growth factor (NGF).
• Are taking indomethacin and/or are suspected of having another
distinct trigeminal autonomic cephalalgia
• A history of migraine variants that could implicate or could be
confused with ischemia
• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
• A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
• Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
• Women who are pregnant or nursing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of LY2951742 compared with placebo in reducing the frequency of weekly cluster headache attacks ;<br> Secondary Objective: To assess the efficacy of LY2951742 compared with placebo on the Patient Global Impression of Improvement (PGI-I).<br> <br> To evaluate the safety and tolerability of LY2951742.<br> ;<br> Primary end point(s): The primary endpoint will be mean change in weekly cluster headache<br> attack frequency with LY2951742 compared with placebo.<br> ;Timepoint(s) of evaluation of this end point: Baseline to week 3/4