A Study in Patients with Chronic Cluster Headache

Phase 1

• Conditions: Chronic Cluster Headache; MedDRA version: 19.1Level: LLTClassification code 10009698Term: Cluster headachesSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-22
• Study Completion: 2019-08-14
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Participants (or patients) with a history of chronc 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 ;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.;Primary end point(s): The primary endpoint will be mean change in weekly cluster headache<br>attack frequency with LY2951742 compared with placebo.;Timepoint(s) of evaluation of this end point: Baseline to week 3/4

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Patients with a 50% or greater reduction in the weekly number of cluster headache attacks<br><br>Patients with a 30% or greater reduction in the weekly number of<br>cluster headache attacks <br><br>Mean change in the weekly cluster headache attack frequency <br><br>Treatment emergent adverse events<br><br>Clinical Laboratory and vital signs<br><br>Anti-LY2951742 antibodies<br><br>Proportion of patients reporting a score of 1 (very much better) or 2<br>(much better) on the Patient Global Impression of Improvement (PGI-I);Timepoint(s) of evaluation of this end point: For first six secondary endpoints from baseline through week 12<br><br>For PGI-I secondary endpoint: at month 1, 2, and 3.