Participants Needed for Episodic Cluster Headache Clinical Research Study
The Alleviate Study: Currently Seeking Subjects Living with Episodic Cluster Headache for a Clinical Research Study
The Alleviate Study will evaluate the effectiveness, safety, and tolerability of the study medicine, eptinezumab, as a possible treatment for episodic Cluster Headache. Eptinezumab is currently approved by the Food and Drug Administration (FDA) as a safe and effective preventive treatment of migraine headaches, but its use for cluster headache is investigational. The purpose of this clinical research study is to determine if the study medicine (eptinezumab) helps to reduce the severity, frequency, and duration of episodic Cluster Headache. The study medicine is administered as an IV infusion over approximately 1 hour. It will be compared to a placebo infusion (a “dummy” infusion that looks like eptinezumab but has no active ingredients). All subjects will receive eptinezumab during the study.
What happens during the Alleviate Study?
Study participation is between 25 and 77 weeks. Once the Cluster Headache cycle begins, the study duration is 25 weeks. During the study, all study participants will receive in a blinded manner one infusion of eptinezumab and one infusion of placebo. The study is divided into the following periods:
- Two Screening Periods:
- Screening Period 1: The study doctor will perform tests to see if you are eligible to participate. You will remain in this screening period until you experience a cluster headache cycle.
- Screening Period 2: When you experience a cluster headache cycle, you will immediately contact the study doctor so they can confirm your
- If you are already in a cluster headache cycle, the two screening periods may be combined.
- Treatment Periods:
- This period is double-blinded, which means neither you nor the study team will know which study treatment group you are You will receive 2 infusions, eptinezumab and placebo, but in a randomly assigned order and blinded towards you and the study doctor.
- Post-treatment Observational Period:
- After you complete the study treatment period, you will continue to be monitored by the study doctor.
- Safety Follow-up Period:
- You will attend a safety follow-up visit 20 weeks after your last infusion.
You may be eligible to participate in the Alleviate Study if you are between the ages of 18 and 75, and you:
- Have a medical history of episodic Cluster Headache prior to age 50
- Have a documented history of episodic Cluster Headache for at least 12
- Have a prior history of cluster period(s) lasting 6 weeks or longer
- Can accurately distinguish between episodic Cluster Headache and other headaches
You may continue to use therapies to abort your Cluster Headache attack. If you are on preventive treatment, you can remain on it, provided the medicines and dose are allowed per protocol. The list of allowed preventive treatments includes medicines that are most commonly used for prevention of Cluster Headache. The study team will discuss the allowed medications with you prior to the start of the study.
If you would like to learn more about the Alleviate Study and find a participating site near you, please visit www.clusterheadachetrial.com.