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Pitolisant for Idiopathic Hypersomnia
Study Summary
This trial is assessing the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia who completed the previous phase of the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” 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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Who is running the clinical trial?
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- My drug screen was negative, except for prescribed medications.I understand and can follow the study's requirements.I understand and can follow the study's requirements.I have severe kidney disease or severe liver disease.I am a woman who can have children, have a negative pregnancy test, and will use birth control during the study.I am taking or cannot stop taking a medication that affects my heart's rhythm.My drug screen was negative, except for prescribed medications.I am a woman who can have children and my pregnancy test was negative.I agree to use non-hormonal birth control or remain abstinent during and 21 days after the study.
- Group 1: Pitolisant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the risks associated with this healing process?
"This therapeutic intervention has been studied multiple times and has shown to be effective and safe. We rate its safety at a 3."
Are there any other places in Canada conducting this research?
"To avoid extensive travelling, patients are encouraged to choose a trial site from the 64 locations that are currently enrolling. These locations include Norwalk, Chicago, Willow Grove and many others."
Are there any more positions available for participants in this clinical trial?
"Unfortunately, this specific trial is not seeking new patients at the moment. The trial was initially posted on 8/19/2022 and was last edited on 9/21/2022. Having said that, there are 21 other trials that are looking for participants right now."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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