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Monoclonal Antibodies
Eptinezumab for Cluster Headache (ALLEVIATE Trial)
Phase 3
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), weeks 1, 2, 3, and 4
Awards & highlights
Pivotal Trial
Summary
This trial is testing eptinezumab, a medication that aims to prevent headaches, in people who have episodic Cluster Headaches. The study will see if eptinezumab reduces headache episodes. Eptinezumab works by blocking signals in the body that cause headaches and has been shown to be effective and safe for the preventive treatment of episodic and chronic migraine.
Eligible Conditions
- Cluster Headache
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0), weeks 1, 2, 3, and 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), weeks 1, 2, 3, and 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
Secondary study objectives
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2
+14 moreSide effects data
From 2020 Phase 3 trial • 485 Patients • NCT041520832%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence 2: Placebo Then EptinezumabExperimental Treatment2 Interventions
Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period
Group II: Sequence 1: Eptinezumab Then PlaceboExperimental Treatment2 Interventions
Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
2021
Completed Phase 3
~2200
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
H. Lundbeck A/SLead Sponsor
329 Previous Clinical Trials
77,478 Total Patients Enrolled
1 Trials studying Cluster Headache
131 Patients Enrolled for Cluster Headache
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
189 Previous Clinical Trials
58,098 Total Patients Enrolled
1 Trials studying Cluster Headache
131 Patients Enrolled for Cluster Headache
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You experienced your first symptoms of cluster headache before the age of 50.You have frequent and severe headaches called episodic cluster headaches, which have been diagnosed by a doctor and have been occurring for at least a year.You are currently experiencing cluster headaches and have had at least one headache attack within the past week.You can tell the difference between your cluster headaches and other types of headaches like tension headaches or migraines.You have chronic pain conditions like fibromyalgia or complex regional pain syndrome that may affect the study results.You have experienced episodes of severe headaches that lasted for 6 weeks or longer without any treatment.You have been diagnosed with certain types of severe headaches or migraines that are not typical or common.You are at a high risk of attempting to harm yourself at the time of the second screening visit.You have a type of headache called episodic cluster headache that has been diagnosed by a doctor for at least a year before the first screening visit.You started experiencing cluster headaches before the age of 60.You have tried medications that target a specific pathway in your body, but they didn't work for you.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 2: Placebo Then Eptinezumab
- Group 2: Sequence 1: Eptinezumab Then Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cluster Headache Patient Testimony for trial: Trial Name: NCT04688775 — Phase 3
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