Episodic Cluster Headache is a rare but disabling headache disorder that can be highly disruptive to your life — personally and professionally. Cluster headache is considered among the most severe of the primary headache disorders because of extreme pain.
The Alleviate Study, for men and women between the ages of 18 and 75, is evaluating a study medicine to determine its effectiveness and safety in reducing the severity, frequency and duration of your episodic Cluster Headache.
The study medicine has been approved by the Food and Drug Administration (FDA) as a preventive treatment of migraine in adults in the United States. For the Alleviate Study, the medicine will be administered as an intravenous (IV) infusion over approximately 1 hour. It will be compared to a placebo infusion (a “dummy” infusion that looks like the study medicine but has no active ingredients). All participants will receive the study medicine during the study.
There is no guarantee that you will be found eligible to participate in this study. You may or may not personally benefit from taking part in this study; your condition may remain the same, improve or could get worse. However, by taking part in this clinical study, you may contribute new information that may benefit patients with episodic Cluster Headache in the future.
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 first symptoms of episodic Cluster Headache at the age of 50 or prior
- Have a documented history of episodic Cluster Headache for at least 12 months
- Have a prior history of cluster period(s) lasting 6 weeks or longer, if you did not receive any treatment for it
- Can distinguish between cluster headache and other headaches
If you pre-qualify, please note that there are additional criteria for entering the study and these will be evaluated together with the study doctor at the Screening visit.
See if you may qualify
Please take a moment to answer the following questions to see if pre-qualify for the Alleviate Study.
The information you provide here will not be stored or shared and will only be used to determine if you, or someone you know, might be eligible for this study.
Please select the study center that is most convenient for you.
Thank you for completing the study prescreening questionnaire.
Unfortunately, based on your responses, you do not pre-qualify for the Alleviate clinical study at this time.
What does participation look like?
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 one intravenous (IV) infusion of the study medicine and one infusion of placebo. The study is divided into the following 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 to confirm your eligibility.
- If you are already in a cluster headache cycle, the two screening periods may be combined.
This period is double-blinded, which means neither you nor the study team will know which study treatment group you are in. You will receive 2 IV infusions, the study medicine and placebo, but in a randomly assigned order and blinded towards you and the study team.
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.
Your first visit with the study doctor will be to determine if you are eligible to participate. This involves completing some tests and procedures. If the study doctor determines you are eligible, and you choose to participate, you will stay in the study until you have your next cluster headache cycle. As soon as your cluster headache cycle begins, you should contact the study doctor to schedule a visit at the site.
- Study appointments are divided into 6 site visits and 4 phone contacts.
- You will receive 2 intravenous (IV) infusions. Each infusion will take approximately 1 hour to administer.
- You will complete a daily electronic diary during the study from Visit 2 until the end of the Post-treatment Observational Period.
- You will complete questionnaires in relation to study site visits and phone contacts.
- 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 is allowed in the study. The list of allowed preventive treatments includes the 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.
Clinical research studies are designed to investigate the effectiveness of potential new medical treatments. Your participation in the Alleviate Study will help researchers to understand whether the study medicine can help reduce the severity, frequency and duration of cluster headache, potentially providing a new treatment option for those suffering from episodic Cluster Headache.
Global study locations
Click the tabs below the map to view participating countries and cities. For most up-to-date listing of study sites, please visit ClinicalTrials.gov.
The interactive map shows the cities where the study is conducted. Please click on the + sign (bottom left) to zoom in on an area, then click the pin to view the city name.
Global Study Locations
Frequently asked questions
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 is allowed in this study. The list of allowed preventive treatments includes the 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 are eligible and choose to participate, you will receive the study medicine and study-related visits, tests and assessments at no cost. You may also be reimbursed for study-related travel expenses.
Study participation is between 25 and 77 weeks. Once the cluster headache cycle begins, the study duration is 25 weeks. There will be 6 site visits and 4 phone contacts.
During a clinical study, you’ll receive the medication that is being studied. This will be done at scheduled times and may occur only once or multiple times throughout the study, depending on the medication. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication, but instead receive a placebo. However, for the Alleviate Study, all participants will receive the study medication during the study. All study volunteers are always closely monitored by clinic staff and the sponsor medical team to ensure their safety.
Placebo: A placebo looks like the study drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, and for any reason.
You’ll first be asked some general questions (here) to help determine whether you meet the basic criteria of the study. If you do meet these criteria, the study contact information will be available. Please reach out to the preferred study site to speak to the study team about a screening visit. At that visit, you’ll be screened to see if you fit the specific qualifications for the study.
There are many reasons to participate in clinical research. It allows participants to play a more proactive role in their own health and receive a potential new treatment for an ongoing disease or condition. Participants also play an important part in bringing much needed drugs to market, benefitting thousands of people who also have the disease or condition.
Participants like you really help make a difference. See if you pre-qualify for this research study.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. Throughout the study, study participants are monitored by study team. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
PRA Health Sciences (PRA), an ICON plc Company is conducting this study on behalf of H. Lundbeck A/S who is responsible for this clinical study.
You may continue to use therapies to abort your episodic Cluster Headache attack. If you are on preventive treatment, you can remain on it, provided the medicines and dose are allowed in this study. The list of allowed preventive treatments includes the medicines that are most commonly used for prevention of cluster headache. This will be discussed on the screening visit.
You will be closely monitored for any side effects throughout the study. Like all medicines, the study medicine could cause side effects, although not everyone will experience them. Most side effects identified for this medication from previous migraine clinical trial data are mild to moderate; however, the possibility of serious side effects that may require treatment cannot be ruled out. You must immediately inform the study doctor if you have any side effects related to the treatment or notice any changes in your health. Any possible side effects of the study medicine will be discussed at the screening visit.
