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Rimegepant for Cluster Headache
Study Summary
This trial is testing if rimegepant can prevent cluster headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your headaches are not caused by another health problem.This criterion requires that a headache is accompanied by at least one of the following:You have been diagnosed with recurrent cluster headaches according to specific guidelines.You have been experiencing cluster headaches that are likely ending within the last 4 weeks.You have had heart problems like a heart attack, heart surgery, or stroke in the past 6 months.You have other pain, mental health issues, memory problems, or serious neurological disorders that could affect the study tests, according to the doctor.You had nerve blocks in certain areas of your body in the month before joining the study.You regularly use opioids or barbiturates for more than 5 days each month.You have taken another medication for migraines in the past month or plan to take it during the study.You have taken CGRP monoclonal antibodies within 3 months before starting the study or during the study.You have cluster headaches caused by a specific problem found in imaging tests like CT or MRI.You have had a bad reaction to CGRP antibodies or another type of CGRP antagonist (gepant) in the past.People with episodic cluster headaches must have had a cluster headache period lasting at least 6 weeks in the past.Redness and tearing in one eye.You have intense, one-sided head or face pain that lasts 15 to 180 minutes when not treated.You had a brain MRI or CT scan after you started having headaches.You must have cluster headaches happening between every other day and eight times a day, with at least four attacks in the past week. If you have episodic cluster headaches, your headache periods must have lasted at least 6 weeks.You have a medical diagnosis of severe, recurring headaches that last between 15 and 180 minutes.Your headache is accompanied by specific symptoms like red eyes, runny nose, or sweating on one side of your face.You have headaches happening every other day up to 8 times a day.Your headaches are not caused by another health problem.You can tell the difference between cluster headaches and other types of headaches like migraines.If you take medicine to prevent headaches, you can still participate if the dose has been the same for at least 2 months (or 6 months for onabotulinumtoxinA injections) and it won't change during the study.
- Group 1: Cluster Headache Subjects
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many research participants are involved in this endeavor?
"Indeed, the information located on clinicaltrials.gov attests to this trial's ongoing recruitment process; it was first posted September 7th 2022 and its most recent update occurred a day prior. The study calls for 10 participants from one medical centre."
Has Rimegepant been given the green light by the FDA?
"While there is evidence that rimegepant possesses a certain degree of safety, as judged by the Phase 2 clinical trial standards, it only achieved a score of 2. This indicates that further studies are necessary to demonstrate its efficacy."
Are there any patient slots available for this experimental trial currently?
"Yes, current information on clinicaltrials.gov points to the fact that this trial is presently enrolling individuals. It was initially posted in September 7th 2022 and updated most recently on July 6th 2022. The research team seeks 10 participants at a single site."
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