A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

Chronic Cluster Headache Clinical Trial

— CHRONICLE  

Official title:

Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064397
• Other study ID #: 19385A
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: July 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

Description:

The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit.

• The participant has a medical history of onset of cluster headache at =50 years of age.

• The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.

• The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).

Exclusion Criteria:

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies [mAbs] and gepants).

• The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).

• The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour).

• Participants with a lifetime history of psychosis, bipolar mania, or dementia. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit.

• The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide.

• The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Intervention

Drug:
• Eptinezumab
Eptinezumab will be administered per schedule specified in the arm description.

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup	Glostrup	Hovedstaden
Denmark	Hospitalsenhed Midt og Regionshospitalet Viborg	Viborg	Midtjylland
Finland	Terveystalo Ruoholahti	Helsinki	Southern Finland
Finland	Terveystalo Turku Pulssi	Turku	Western Finland
France	Hôpital Pierre Wertheimer	Bron	Rhône
France	Hôpital Roger Salengro	Lille	Nord
France	Hôpital de la Timone	Marseille Cedex 5	Provence Alpes Cote d'Azur
France	Hôpital Cimiez	Nice Cedex 1	Côte-d'Or
France	Hôpital Lariboisière	Paris	Île-de-France
France	Centre Hospitalier Universitaire de Saint-Étienne	Saint-Priest-en-Jarez	Rhône
Germany	Charité Campus Mitte	Berlin
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt/ Main	Hessen
Italy	IRCCS Istituto Delle Scienze Neurologiche di Bologna	Bologna
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...	Milano	Milan
Italy	Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS	Pavia
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana	Rome	Roma
Italy	Ospedale Molinette - Clinica Neurologica II - Centro Cefalee	Turin
Netherlands	Brain Research Center - Amsterdam	Amsterdam	Noord-Holland
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen	Gelderland
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Clínico Universitario de Valencia	València
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool	England
United Kingdom	King's College Hospital NHS Foundation Trust	London	England
United States	Dent Neurologic Institute - Amherst	Amherst	New York
United States	Michigan Headache and Neurological Institute	Ann Arbor	Michigan
United States	Cleveland Clinic - Neurological Institute	Cleveland	Ohio
United States	Thomas Jefferson University Hospital - Center City Campus	Philadelphia	Pennsylvania
United States	New England Institute for Neurology and Headache	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Secondary	Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache: Number of Participants With No Cluster Headache Attacks for =3 Consecutive Months (=13 Consecutive Weeks)		Baseline (Week 0) to Week 48
Secondary	Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used, Averaged Over the First 4 Weeks After Each Infusion		Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Secondary	Change From Baseline in the Average Number of Weekly Attacks, Averaged Over the First 4 Weeks After Each Infusion		Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Secondary	Change From Baseline in the 5-Point Self-Rating Pain Severity Scale, Averaged Over the First 4 Weeks After Each Infusion		Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Secondary	Response: Number of Participants With =30% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion		Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Secondary	Response: Number of Participants With =50% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion		Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Secondary	cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks)		Baseline (Week 0) to Week 48
Secondary	cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the First and Second Infusion)		Baseline (Week 0) to Week 12
Secondary	cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the Second and Third Infusion)		Week 12 to Week 24
Secondary	cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the Third and Fourth Infusion)		Week 24 to Week 36
Secondary	cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)		Week 36 to Week 48
Secondary	Number of Participants who Received a Transitional Therapy During the Treatment Period		Week 0 to Week 48
Secondary	Patient Global Impression of Change (PGIC) Score		Baseline (Week 0) up to Week 48
Secondary	Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time		Baseline (Week 0) up to Week 40
Secondary	Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48		Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
Secondary	Health Care Resources Utilization (HCRU) Score		Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
Secondary	Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48		Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48