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Completed

NCT Number: NCT05064397

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rigshospitalet Glostrup, Glostrup Municipality, Capital Region, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab

Drug

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

Other names: Vyepti

Primary outcomes

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

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

    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.

Secondary outcomes

  1. 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)

    Time frame: Week 1 to Week 48

    Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months.

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

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

    Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack.

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

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

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

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

  5. Change From Baseline in the Average Number of Weekly Attacks

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

    The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks.

  6. Change From Baseline in the Number of Weekly Attacks

    Time frame: Baseline (Week 0), Weeks 1-4

    The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown.

  7. Change From Baseline in the Number of Weekly Attacks

    Time frame: Baseline (Week 0), Weeks 1-2

    The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown.

  8. Change From Baseline in the Number of Monthly Attacks

    Time frame: Baseline (Week 0), Months 1-12

    The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown.

  9. Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale

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

    The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).

  10. Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks

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

  11. Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks

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

  12. Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks

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

  13. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)

    Time frame: Week 1 to Week 48

    Participants counted as being in remission if they had no cluster headache attacks for at least 1 month.

  14. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)

    Time frame: Week 1 to Week 12

  15. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)

    Time frame: Week 13 to Week 24

  16. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)

    Time frame: Week 25 to Week 36

  17. cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)

    Time frame: Week 37 to Week 48

  18. Number of Participants Who Received a Transitional Therapy During the Treatment Period

    Time frame: Week 1 to Week 48

    Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids.

  19. Patient Global Impression of Change (PGIC) Score

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

    The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.

  20. Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time

    Time frame: Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48

    The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.

  21. Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    The EQ-5D-5L is a patient-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems).

  22. Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

  23. 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

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.

  24. Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    Number of participants who visited a family doctor/general practitioner has been reported.

  25. Health Care Resource Utilization - Number of Visits to a Specialist

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    Number of participants who visited a specialist has been reported.

  26. Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    Number of participants who visited an emergency department due to CH has been reported.

  27. Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    Number of participants admitted to the hospital due to CH has been reported.

  28. Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache

    Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48

    Number of participants who had overnight hospital stays due to CH has been reported.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Acronym: CHRONICLE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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