Research

Clinical Trials

Patient engagement in clinical trials help find new ways to treat individuals with narcolepsy.

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.

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.

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. We hope to develop and validate this Pediatric Hypersomnia Screening Tool for use in schools and health care settings. Diagnostic delays for pediatric hypersomnia conditions are common and often results in academic and social difficulties for children and adolescents. We hope this tool will both raise awareness of narcolepsy and prompt referrals to appropriate pediatric specialists for faster diagnoses. This study is funded by the American Sleep Medicine Foundation and Coverys Community Health Care Foundation.

Who can participate: We are looking for otherwise healthy patients between the ages of 8-18 years who are awaiting diagnostic testing with a sleep study (polysomnography and multiple sleep latency test) for the diagnosis of Narcolepsy or Idiopathic Hypersomnia.

What will participants have to do? Participants will be asked to fill out a survey online that will take no longer than 10 minutes, and then complete an additional 2 minute follow-up survey one week later. We will require you sign a waiver so we can obtain final sleep study results.

The study provides a $10 gift card as a token of appreciation. If you are interested in participating in this study or would like more information, please contact Elaina Little at Elaina.Little@childrens.harvard.edu or call 617-919-6212.