Clinical Trials/NCT04688775

NCT04688775

Completed

Phase 3

Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache

H. Lundbeck A/S120 sites in 7 countries231 target enrollmentDecember 23, 2020

ConditionsCluster Headache, Episodic

InterventionsEptinezumab Placebo

DrugsEptinezumab Placebo

Overview

Phase: Phase 3
Intervention: Eptinezumab
Conditions: Cluster Headache, Episodic
Sponsor: H. Lundbeck A/S
Enrollment: 231
Locations: 120
Primary Endpoint: Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Detailed Description

Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period and Active Treatment Period of the study. The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Registry

clinicaltrials.gov

Start Date

December 23, 2020

End Date

October 5, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participant has episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit
•The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated.
•The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine).
•The participant is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit
•The participant has a medical history of first symptoms of cluster headache from ≤60 years of age.
•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 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 brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
•Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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 2 are also excluded.

Exclusion Criteria

Not provided

Arms & Interventions

Sequence 1: Eptinezumab Then Placebo

Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period

Intervention: Eptinezumab

Sequence 1: Eptinezumab Then Placebo

Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period

Intervention: Placebo

Sequence 2: Placebo Then Eptinezumab

Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period

Intervention: Eptinezumab

Sequence 2: Placebo Then Eptinezumab

Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2

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

The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.

Secondary Outcomes

Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2(Baseline (Week 0), Weeks 1-2)
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2(Baseline (Week 0), Weeks 1-2)
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2(Baseline (Week 0), Weeks 1-2)
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1(Baseline (Week 0), Week 1)
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1(Baseline (Week 0), Week 1)
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3(Baseline (Week 0), Days 1-3)
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2(Baseline (Week 0), Weeks 1-2)
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2(Baseline (Week 0), Weeks 1-2)
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain(Baseline (Week 0), Week 1)
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain(Baseline (Week 0), Week 2)
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4(Baseline (Week 0), Weeks 1-4)
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4(Baseline (Week 0), Weeks 1-4)
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4(Baseline (Week 0), Weeks 1, 2, 3, and 4)
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4(Baseline (Week 0), Weeks 3-4)
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4(Weeks 1, 2, and 4)
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4(Baseline (Week 0), Weeks 2 and 4)
HCRU Score: Number of Hospital Admissions Due to Cluster Headache(Week 4)
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks(From first infusion (Baseline, Day 0) to 4 weeks)
Change From Baseline to Week 2 in the Number of Weekly Attacks(Baseline (Week 0), Week 2)
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP(From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period)
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3(Baseline (Week 0), Days 1-3)
Change From Baseline to Week 1 in the Number of Weekly Attacks(Baseline (Week 0), Week 1)
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4(Baseline (Week 0), Weeks 2 and 4)
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner(Week 4)
HCRU Score: Number of Visits to a Specialist(Week 4)
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache(Week 4)
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache(Week 4)
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4(Baseline (Week 0), Week 4)