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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05064397
Collaborator
(none)
131
Enrollment
31
Locations
1
Arm
21.4
Anticipated Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. 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]

    6. 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]

    7. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks) [Baseline (Week 0) to Week 48]

    8. 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]

    9. 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]

    10. 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]

    11. 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]

    12. Number of Participants who Received a Transitional Therapy During the Treatment Period [Week 0 to Week 48]

    13. Patient Global Impression of Change (PGIC) Score [Baseline (Week 0) up to Week 48]

    14. Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time [Baseline (Week 0) up to Week 40]

    15. 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]

    16. Health Care Resources Utilization (HCRU) Score [Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48]

    17. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT05064397
    Other Study ID Numbers:
    • 19385A
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cluster Headache
    Headache

    Study Results

    No Results Posted as of Aug 5, 2022