Eptinezumab in Participants With Episodic Cluster Headache

(ALLEVIATE Trial)

Recruiting at 143 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: H. Lundbeck A/S

Must not be taking: Anti-CGRP mAbs, Gepants

Disqualifiers: Psychosis, Bipolar, Dementia, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

231 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug Eptinezumab differ from other treatments?

Eptinezumab is unique because it is administered intravenously (through a vein) and is designed to prevent migraines by targeting a specific protein involved in migraine attacks. This differs from many other migraine treatments that are taken orally and focus on treating symptoms after they start. ^{1 2 3 4 5}

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

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.

You have chronic pain conditions like fibromyalgia or complex regional pain syndrome that may affect the study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-controlled Period

Participants receive either eptinezumab or placebo in a blinded manner

8 weeks

2 infusions

Active Treatment Period

Participants receive the alternate treatment (eptinezumab or placebo) in a cross-over manner

8 weeks

2 infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Eptinezumab

Participant Groups

Group I: Sequence 2: Placebo Then Eptinezumab Experimental Treatment 2 Interventions

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

Group II: Sequence 1: Eptinezumab Then Placebo Experimental Treatment 2 Interventions

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

Eptinezumab is already approved in United States for the following indications:

Approved in United States as Vyepti for:

• Preventive treatment of migraine in adults

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden

Findings from Research

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Proteolytic single hinge cleavage of pertuzumab impairs its Fc effector function and antitumor activity in vitro and in vivo. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Properties and structure-function relationships of veltuzumab (hA20), a humanized anti-CD20 monoclonal antibody. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. [2018]