Chronic Cluster Headache MedDRA version: 20.0 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852
Conditions
Interventions
Product Name: galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: galcanezumab
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). To evaluate the safety and tolerability of LY2951742. ;Primary end point(s): The primary endpoint is the overall mean change from baseline in weekly cluster headache attack frequency during the 12-week double blind treatment phase with LY2951742 compared with placebo.;Timepoint(s) of evaluation of this end point: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patients with a 50% or greater reduction in the weekly number of cluster headache attacks Patients with a 30% or greater reduction in the weekly number of cluster headache attacks Mean change in the weekly cluster headache attack frequency Treatment emergent adverse events Clinical Laboratory and vital signs Anti-LY2951742 antibodies Proportion of patients reporting a score of 1 ("very much better") or 2 ("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 For PGI-I secondary endpoint: at month 1, 2, and 3. | — |
Countries
Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed