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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Cluster Headache
• Intervention / Treatment: Drug: Eptinezumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hovedstaden
    • Glostrup, Hovedstaden, Denmark, 2600
      • Rigshospitalet Glostrup
  • Midtjylland
    • Viborg, Midtjylland, Denmark, 8800
      • Hospitalsenhed Midt og Regionshospitalet Viborg
• Finland
  • Southern Finland
    • Helsinki, Southern Finland, Finland, 00180
      • Terveystalo Ruoholahti
  • Western Finland
    • Turku, Western Finland, Finland, 20100
      • Terveystalo Turku Pulssi
• France
  • Côte-d'Or
    • Nice Cedex 1, Côte-d'Or, France, 91179 - 06003
      • Hôpital Cimiez
  • Nord
    • Lille, Nord, France, 59037
      • Hôpital Roger Salengro
  • Provence Alpes Cote d'Azur
    • Marseille Cedex 5, Provence Alpes Cote d'Azur, France, 13005
      • Hôpital de la Timone
  • Rhône
    • Bron, Rhône, France, 69677
      • Hôpital Pierre Wertheimer
    • Saint-Priest-en-Jarez, Rhône, France, 42055
      • Centre Hospitalier Universitaire de Saint-Étienne
  • Île-de-France
    • Paris, Île-de-France, France, 75010
      • Hopital Lariboisiere
• Germany
  • Berlin, Germany, 10117
    • Charité Campus Mitte
  • Hessen
    • Frankfurt/ Main, Hessen, Germany, 65929
      • Kopfschmerzzentrum Frankfurt
• Italy
  • Bologna, Italy, 40123
    • IRCCS Istituto delle Scienze Neurologiche di Bologna
  • Pavia, Italy, 27100
    • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
  • Turin, Italy, 10126
    • Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
  • Milan
    • Milano, Milan, Italy, 20133
      • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
  • Roma
    • Rome, Roma, Italy, 00163
      • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 GN
      • Brain Research Center - Amsterdam
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valladolid, Spain, 47010
    • Hospital Clínico Universitario de Valladolid
  • València, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
• United Kingdom
  • England
    • Liverpool, England, United Kingdom, L9 7LJ
      • The Walton Centre NHS Foundation Trust
    • London, England, United Kingdom, SE5 9RS
      • King's College Hospital NHS Foundation Trust
• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Neurology and Headache
  • Michigan
    • Ann Arbor, Michigan, United States, 48104-5131
      • Michigan Headache and Neurological Institute
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute - Amherst
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic - Neurological Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital - Center City Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eptinezumab; 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; Eptinezumab will be administered per schedule specified in the arm description.; Other Names: Vyepti

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events	From the day of first dose of study drug (Baseline [Week 0]) up to Week 56

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
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
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks)	Baseline (Week 0) to Week 48
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
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
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
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
Number of Participants who Received a Transitional Therapy During the Treatment Period	Week 0 to Week 48
Patient Global Impression of Change (PGIC) Score	Baseline (Week 0) up to Week 48
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time	Baseline (Week 0) up to Week 40
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
Health Care Resources Utilization (HCRU) Score	Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: 19385A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No