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Efficacy of Erenumab in Chronic Cluster Headache

CompletedPhase 2NCT04970355
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Efficacy of Erenumab in Chronic Cluster Headache: A 10 Week Double-blind, Randomized, Placebo Controlled, Multicentric Trial.
Conditions
  • Cluster Headache
  • Trigeminal Autonomic Cephalalgias
  • Headache Disorders, Primary
  • Brain Disease
Sponsor
Charite University, Berlin, Germany
Start date
2021-12-02
Primary completion
2023-09-27
Sex
All
Age range
from 18 Years to 64 Years
Results posted
No results posted in this snapshot
Countries
Germany
Total sites listed
11

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria (screening) * 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). Inclusion Criteria (Baseline) * At least 9 cluster headache attacks as defined by the ICHD-3 in 7 days during the baseline epoch (SPII), confirmed by patient-reported eDiary entries. * Attacks must have occurred on more than 50% of days of the baseline epoch (SPII). * ≥ 90% patient-reported eDiary compliance during the Baseline epoch, compliance is measured as interacting with e-Diary at least once a day. 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 and migraine as defined in criterion 2. * Headache freedom from the historic diagnosis of migraine has to be at least one year prior to study inclusion. If patients have on average \<=1 migraine attack per month within a year and can distinguish between migraine attacks and cluster attacks, they are allowed to participate. * 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 * Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer * Evidence of drug, opioid or alcohol abuse o…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04970355