What Is A Clinical Trial?

A clinical trial is any research study that evaluates interventions to prevent, detect, diagnosis, or treat a disease or disorder. In a clinical trial, human participants (or groups of participants) are assigned to one or more interventions to assess the results on health outcomes.

Why Are Clinical Trials Important?

Clinical Trials are important in discovering new treatments to prevent, detect, diagnosis, or treat narcolepsy. It is the only process to bring new pharmacological drugs and treatments forward for approval to use within the narcolepsy community. Without the clinical trials, there is a risk that individuals could be given treatments which have no advantage, waste time, and could even be harmful to one’s health. If a treatment has no benefit, or has serious side effects, the treatment may not be further developed.

Ongoing Research

New Clinical Trail through Concert Study- See if You are Eligible!

Axsome is developing a new medication to treat EDS and Cataplexy called AXS-12. if you would like to participate in the clinical trial process click the link below to see if you qualify. Here is their announcement.

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Axsome Therapeutics is pleased to announce a new clinical trial of an investigational oral medication, AXS-12, for the treatment of excessive day time sleepiness and cataplexy associated with narcolepsy. Participation in this study may last up to 9 weeks. All enrolled subjects will receive study-related care at no cost.

You may be eligible if you: *

Are 18-65 years old Have a diagnosis of narcolepsy with cataplexy.

*The study doctor will discuss additional requirements.

Study sites are located in the following cities: New York, NY; Cincinnati, OH; Miami, FL; Chevy Chase, MD; Austin, TX; Alameda, CA; Colombia, SC; St. Petersburg, FL.

To find out more information about this trial and to see if you qualify, please visit www.theconcertstudy.com or https://clinicaltrials.gov/show/NCT03881852

Recruiting Participants with Excessive Sleepiness

WUN is collaborating with Hypersomnia Foundation and Dr. Thanh Dang-Vu to investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia.

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Who can participate: We are looking for patients 18 years or more who have been diagnosed with Narcolepsy (with or without cataplexy) or Idiopathic Hypersomnia.

What are the factors that may exclude you from participating? 1- Other sleep disorders, 2- Neurological disorders or head trauma, 3-Psychiatric disorders or use of psychotropic drugs, 4- Pregnancy or breastfeeding and 5-Pacemaker or metallic prosthesis

What will participants have to do?  To investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia. This study includes two (non- consecutive) overnight sleep sessions at the sleep laboratory and a MRI scan session.

If you are interested by this study, please contact: Elizaveta Frolova, research coordinator. Email: hypersomnia.research@gmail.com

Help Improve Delays in Diagnosing Narcolepsy!

WUN is collaborating with Boston Children’s Hospital (PI Dr. Kiran Maski) to develop a screening tool to identify children and adolescents with narcolepsy and idiopathic hypersomnia in the community.

Dr. Kiran Maski, a sleep physician and researcher has have developed a questionnaire that will improve screening for narcolepsy in schools. We hope this survey will help school professionals identify narcolepsy symptoms in a school setting. We are looking for participants to fill out our survey online and we will provide a gift card as a token of appreciation. Participation should take no more than 15 minutes.

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Who is eligible for this study?

1)       Children between the ages of 6-18 years and their parents/guardians

2)       Children or young adults being treated for narcolepsy

3)       Participants must be able to understand the purpose of the study

If you would like to learn more about the study or are interested in participating, please contact us  at NeuroSleepResearch-dl@childrens.harvard.edu or call 617-355-9184.

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