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

RESTORE

** Find participating sites at ClinicalTrials.gov NCT#: NCT04451668

If you or your child are over 16 and have been diagnosed with narcolepsy, you may qualify for a research study.

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If you or your child are over 16 and have been diagnosed with narcolepsy, you may qualify for a research study.

 

Managing your narcolepsy symptoms is challenging, so learning all your treatment options is very important. One option to consider is the RESTORE study of an investigational medicine, FT218, which is a once‐nightly formulation of sodium oxybate.

In this study, FT218 will be taken orally once per night, before you go to bed, for up to two years. You’ll be asked to complete in‐person or virtual study visits about four times per year and also complete some brief questionnaires.

Who is eligible to participate in this study?

To qualify, you or your child must:

• Be 16 years of age or older

• Be diagnosed with narcolepsy with or without cataplexy

• Have completed the REST‐ON Study and/or be receiving twice‐nightly sodium oxybate

** Find participating sites at ClinicalTrials.gov NCT#:NCT04451668**

 Do daytime “sleep attacks” leave you dreaming about a better treatment for narcolepsy?

SUVN‑G3031 study: Clinical Trial Listing

Do you have excessive daytime sleepiness from narcolepsy? You may be interested to learn about SUVN-G3031, a research study evaluating an investigational product for narcolepsy with and without cataplexy.

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Do daytime “sleep attacks” leave you dreaming about a better treatment for narcolepsy?

Do you have excessive daytime sleepiness from narcolepsy? You may be interested to learn about SUVN-G3031, a research study evaluating an investigational product for narcolepsy with and without cataplexy. Currently, there are treatments available that can increase alertness and improve daytime performance in people with narcolepsy. There are also treatments available to help improve the effects of cataplexy. Doctors continue to research treatments through clinical studies because a single safe and effective treatment for multiple symptoms is still unavailable.

The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug.

 

What will happen in this study?

If you are eligible to enroll in this study, you will be in this study for approximately 7 weeks, and you will need to come to the study center at least 5 times over this period. You will take either the study drug tablet or a placebo tablet once every day for 14 days. You will stay overnight at the study clinic 3 times for a sleep study and other study procedures. You will also come to the study clinic for a safety follow-up visit.

 

Who is eligible to participate in this study?

To be eligible for this study, you must be:

  • Be between 18 and 50 years of age
  • Have a diagnosis of narcolepsy confirmed by a sleep study

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.

Qualified participants will receive all study-related exams, care and medications at no cost. Compensation for time and travel may be available.

If you are interested in learning more, visit www.SuddenSleepStudy.com. 

Do you or your child have a diagnosis of narcolepsy or idiopathic hypersomnia?

Do you or your child have a diagnosis of narcolepsy or idiopathic hypersomnia?

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If you or your child have received a diagnosis of narcolepsy or IH within the last year and are between the ages of 8-18 years old, you may be eligible to participate in our research study. We are aiming to improve screening for pediatric narcolepsy and idiopathic hypersomnia. The research study involves filling out quick surveys online about you or your child’s sleepiness. Participation will take between 15-20 minutes in total.

Compensation for participating in the study is $10

 

For more information please contact us at: 617-919-6212 or email 

NeuroSleepResearch-dl@childrens.harvard.edu                          

The Sparkle 1501 Study for Narcolepsy

At Wake Up Narcolepsy one of our priorities is to help advance the medical understanding about narcolepsy with cataplexy. We know that is a priority for you too.

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 Further development is needed in treating narcolepsy, a sleep disorder that disrupts the brain’s ability to regulate sleep-wake cycles, causing persistent sleepiness throughout the day. 

 

What is the purpose of the Sparkle 1501 Study?

This clinical study is testing an investigational drug (TAK-994) to see how safe and tolerable it is and how it affects a person’s narcolepsy symptoms. 

Is study participation an option for me?

 

You may qualify if you:

  • Are 18–65 years old
  • Have been diagnosed with narcolepsy with or without cataplexy
  • Experience excessive daytime sleepiness 
  • Have narcolepsy with cataplexy and experience more than or equal to 4 partial or complete episodes of cataplexy/week 
  • Are willing to stop taking narcolepsy and cataplexy medications during study participation
  • Meet additional requirements as determined by a screening process

 

A study doctor and staff can explain to you in greater detail other requirements and eligibility criteria you would have to meet to participate in the study.  Travel support and compensation for study participation may be available.

To learn more about the Sparkle 1501 Study and to see if you may qualify, visit http://bit.ly/2PsEyEm.

The Sparkle 2002 Study for Idiopathic Hypersomnia

If you have idiopathic hypersomnia or simply IH, you may be able to help with research designed to develop a new treatment options.

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Idiopathic hypersomnia presents daily challenges and frustrations. You may struggle with activities that others take for granted, such as working, driving, and watching television. Even spending time with family and friends can be difficult when you’re constantly fighting to stay awake.

Further development is needed in treating sleep disorders. 

 

What is the purpose of the Sparkle 2002 Study?

This clinical study is testing an investigational drug (TAK-925) to see if it could potentially be a safe and effective way to help increase wakefulness for people with idiopathic hypersomnia. 

 

Is study participation an option for me?

You may qualify if you:

  • Are 18–75 years old
  • Have been diagnosed with idiopathic hypersomnia
  • First experienced the effects of hypersomnia when you were between 10 and 30 years old
  • Meet additional requirements as determined by a screening process

A study doctor and staff can explain to you in greater detail other requirements and eligibility criteria you would have to meet to participate in the study.  You will be reimbursed for your time and travel

 

To learn more about the Sparkle 2002 Study and to see if you may qualify, visit http://bit.ly/3aaKp9j. 

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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