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Eptinezumab for Cluster Headache (ALLEVIATE Trial)
ALLEVIATE Trial Summary
This trial will test if eptinezumab is effective in treating episodic cluster headaches.
- Cluster Headache
ALLEVIATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 485 Patients • NCT04152083ALLEVIATE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Sequence 2: Placebo Then Eptinezumab
- Group 2: Sequence 1: Eptinezumab Then Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
At how many different locations is this experiment being conducted?
"This clinical trial has active locations in 25 states, including Headache Center in Lebanon, Mayo Clinic - Arizona in Scottsdale, and Dent Neurologic Institute - Amherst in Amherst."
What is the latest word on Eptinezumab from the FDA?
"Eptinezumab is considered safe and received a score of 3. This is because there is already some data supporting its efficacy and multiple rounds of safety data from clinical trials."
How can I sign up for this opportunity to test a new medication?
"Eligible participants for this study must suffer from episodic cluster headaches and be between 18-75 years old. The trial is looking to enroll 304 individuals in total."
What other scientific research has been undertaken with Eptinezumab?
"At the moment, there are 7 separate clinical trials studying eptinezumab. Of those, 6 are in Phase 3. The largest number of research sites for eptinezumab is located in Moscow and Île-de-France; however, this treatment is being studied at a total of 291 locations worldwide."
What other similar research exists for this topic?
"Eptinezumab was first studied in 2020 and has since gone through several trials. The most recent study was conducted in 2020 and sponsored by H. Lundbeck A/S. After the initial trial, which involved 32 patients, Eptinezumab received Phase 1 drug approval. Today, there are 7 active studies for Eptinezumab across 130 cities and 25 countries."
Are volunteers still being accepted for this trial?
"The latest information on clinicaltrials.gov suggests that this research trial is still looking for participants. The listing was created on December 23rd, 2020 and updated November 14th, 2022."
Are people who are over 30 years old able to participate in this particular clinical trial?
"This trial's requirements state that participants must be aged 18-75. If an applicant doesn't meet this age criteria, they might consider one of the 23 other trials for patients under 18 or 102 trials meant for those over 65."
How many test subjects are a part of this experiment?
"In order to conduct this study, a total of 304 participants that meet the eligibility requirements are needed. The sponsor, H. Lundbeck A/S, will be managing the clinical trial from various locations including Headache Center in Lebanon, New hampshire and Mayo Clinic - Arizona in Scottsdale, Arizona."
Who else is applying?
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