A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) (CHRONICLE)
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| ClinicalTrials.gov Identifier: NCT05064397 |
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Recruitment Status :
Active, not recruiting
First Posted : October 1, 2021
Last Update Posted : January 19, 2023
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Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
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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 |
|---|---|---|
| Chronic Cluster Headache | Drug: Eptinezumab | Phase 3 |
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 (Clinical Trial) |
| 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 : | September 17, 2021 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Eptinezumab
Eptinezumab will be administered per schedule specified in the arm description.
Other Name: Vyepti |
Primary Outcome Measures :
- Number of Participants With Adverse Events [ Time Frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064397
Locations
Show 31 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | H. Lundbeck A/S |
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT05064397 |
| Other Study ID Numbers: |
19385A |
| First Posted: | October 1, 2021 Key Record Dates |
| Last Update Posted: | January 19, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Cluster Headache Headache Pain Neurologic Manifestations Trigeminal Autonomic Cephalalgias |
Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |