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

• ClinicalTrials.gov Identifier: NCT05064397
• Recruitment Status: Completed
• First Posted: October 1, 2021
• Last Update Posted: July 12, 2023
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Tracking Information

• First Submitted Date: September 22, 2021
• First Posted Date: October 1, 2021
• Last Update Posted Date: July 12, 2023
• Actual Study Start Date: September 17, 2021
• Actual Primary Completion Date: June 29, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 22, 2021): Number of Participants With Adverse Events [ Time Frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2021)

• 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 36 to Week 48 ]
• Number of Participants who Received a Transitional Therapy During the Treatment Period [ Time Frame: Week 0 to Week 48 ]
• Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline (Week 0) up to Week 48 ]
• Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time [ Time Frame: 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 [ Time Frame: Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48 ]
• Health Care Resources Utilization (HCRU) Score [ Time Frame: 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 [ Time Frame: Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
• Official Title: Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache
• 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Cluster Headache

Intervention

Drug: Eptinezumab

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

Other Name: Vyepti

Study Arms

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.

Intervention: Drug: Eptinezumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2022): 131
• Original Estimated Enrollment (submitted: September 22, 2021): 125
• Actual Study Completion Date: June 29, 2023
• Actual Primary Completion Date: June 29, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05064397
• Other Study ID Numbers: 19385A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: H. Lundbeck A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: H. Lundbeck A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: H. Lundbeck A/S
• Verification Date: July 2023