Loading clinical trials...

Efficacy of Erenumab in Chronic Cluster Headache | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy of Erenumab in Chronic Cluster Headache

Efficacy of Erenumab in Chronic Cluster Headache: A 10 Week Double-blind, Randomized, Placebo Controlled, Multicentric Trial.

NCT04970355•Charite University, Berlin, Germany

View on ClinicalTrials.gov

Summary

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

Detailed Description

The purpose of this study is to determine the efficacy of erenumab in a loading dose of 280mg followed by 140mg after 4 weeks compared to placebo as a prophylactic treatment in patients with chronic cluster headache. This study has a 10-week 2-arm, randomized, double-blind, parallel- group, placebo-controlled design. Data from this study will provide important information if the blockade of the CGRP receptor with erenumab is an efficacious principle for the treatment of chronic cluster headache

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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).
•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 or dependence within 12 months prior to screening, based on medical records or patient self-report
+19 more criteria

Locations (11)

LMU Klinikum München

München, Bavaria, Germany

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Hesse, Germany

Vitos - Orthopädische Klinik gGmbH

Kassel, Hesse, Germany

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Praxis für Neurologie, Nervenheilkunde, Psychosomatik

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinik Dresden

Dresden, Saxony, Germany

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Schmerzklinik Kiel - Migräne- und Kopfschmerzzentrum

Kiel, Schleswig-Holstein, Germany

Key Dates

Start Date

December 2, 2021

Primary Completion Date

September 27, 2023

Completion Date

September 27, 2023

Last Updated

January 23, 2024

Enrollment

101

ACTUAL participants

Conditions

Cluster HeadacheTrigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryBrain Disease

Interventions

Erenumab

BIOLOGICAL

Placebo

DRUG

China HeadAche DIsorders RegiStry

NCT05334927

Headache Disorders, PrimaryMigraine+4 more

View study

RECRUITING

China Headache and Vertigo Registry Study

NCT04939922

Headache Disorders, PrimaryHeadache Disorders, Secondary+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of Erenumab in Chronic Cluster Headache

Inclusion Criteria

Exclusion Criteria

China HeadAche DIsorders RegiStry

China Headache and Vertigo Registry Study

International Headache Registry Study

Sphenopalatine Ganglion Pulsed Radiofrequency Treatment Outcomes

Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study

Personalised Process-based Psychological Interventions for Paediatric Headaches