Efficacy of Erenumab in Chronic Cluster Headache

• Status: Not yet recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy of erenumab in participants with chronic cluster headache.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Erenumab

Criteria

Inclusion Criteria:

• Adults ≥18 and < 65 years of age

• Documented history of chronic cluster headache for ≥12 months prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3)

• Participants are able to distinguish cluster headache attacks from other headaches.

• Insufficient efficacy OR tolerability OR contraindications of approved cluster headache prophylactic medications. Insufficient efficacy and tolerability as determined by the patient.

• Sufficient acute attack treatment with triptans or oxygen based on the patient´s history

• The patient is able to distinguish cluster headache attacks from other headaches (i.e.tension-type headaches).

Exclusion Criteria:

• Diagnosis or history of other primary headache diseases according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), excluding episodic tension type headache.

• Unable to differentiate cluster headache attacks from other headaches

• Use of a prophylactic cluster headache medication within 5 half-lives prior to the start of the baseline phase

• Parallel use of an SPG stimulator, deep brain stimulation or parallel use of a device for the acute/preventive treatment of chronic cluster headache

• Administration of botulinum toxin type A or B in the head or neck area, within 4 months of baseline (SP II)

• Concurrent use of other therapeutic monoclonal antibodies.

• Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor

• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic protein

• 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.