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

NCT05064397 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 19385A
• Study Type: interventional
• Target: 131
• Locations: 9 countries
• Sites: 31

Brief Summary

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

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (AEs)

  A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  From the day of first dose of study drug (Baseline [Week 0]) up to Week 56

Secondary Outcomes (28)

• Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks)

  Week 1 to Week 48

• Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used

  Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40

• Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used

  Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40

• Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used

  Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40

• Change From Baseline in the Average Number of Weekly Attacks

  Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40

Study Arms (1)

Eptinezumab

EXPERIMENTAL

Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

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

Also known as: Vyepti

Eptinezumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (31)

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, 48104-5131, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University Hospital - Center City Campus

Philadelphia, Pennsylvania, 19107, United States

Location

Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Hospitalsenhed Midt og Regionshospitalet Viborg

Viborg, Central Jutland, 8800, Denmark

Location

Terveystalo Ruoholahti

Helsinki, Southern Finland, 00180, Finland

Location

Terveystalo Turku Pulssi

Turku, Western Finland, 20100, Finland

Location

Hôpital Cimiez

Nice, Côte-d'Or, 91179 - 06003, France

Location

Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Hôpital de la Timone

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

Location

Hôpital Pierre Wertheimer

Bron, Rhône, 69677, France

Location

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Priest-en-Jarez, Rhône, 42055, France

Location

Hôpital Lariboisière

Paris, Île-de-France Region, 75010, France

Location

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Hesse, 65929, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...

Milan, Milan, 20133, Italy

Location

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Rome, Roma, 00163, Italy

Location

IRCCS Istituto Delle Scienze Neurologiche di Bologna

Bologna, 40123, Italy

Location

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, 27100, Italy

Location

Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

Turin, 10126, Italy

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Brain Research Center - Amsterdam

Amsterdam, North Holland, 1081 GN, Netherlands

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47010, Spain

Location

The Walton Centre NHS Foundation Trust

Liverpool, England, L9 7LJ, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Tassorelli C, Jensen RH, Goadsby PJ, Charles AC, Tepper SJ, Snoer AH, Josiassen MK, Linander CB, Ettrup A, Sperling B, Boneva N. Long-term safety, tolerability, and efficacy of eptinezumab in chronic cluster headache (CHRONICLE): an open-label safety trial. Lancet Neurol. 2025 May;24(5):429-440. doi: 10.1016/S1474-4422(25)00065-1.

  PMID: 40252664 DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+45 36301311

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: September 17, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Locations

ES (5); GB (2); DK (2); FR (6); DE (2); FI (2); NL (2); US (5); IT (5)