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

Focus Group Participants Needed to Develop a Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)

Share your experience living with narcolepsy!

Narcolepsy is a chronic neurologic condition that tends to occur most frequently during childhood and adolescence. Currently there is no tool to assess the symptoms of narcolepsy that most significantly impact daily functioning of children with narcolepsy.

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Focus Group Participants Needed to Develop a Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)

Narcolepsy is a chronic neurologic condition that tends to occur most frequently during childhood and adolescence. Currently there is no tool to assess the symptoms of narcolepsy that most significantly impact daily functioning of children with narcolepsy. We are conducting a study to develop a clinical tool health care providers can use to assess pediatric narcolepsy symptoms.

Pediatric patients with narcolepsy and their parent/guardian are invited to take part in a 90 minute on-line, recorded focus group to discuss narcolepsy symptoms and the impact of the symptoms. As a thank you for participating in the focus group, you will receive a $50 gift card.

 

Who is eligible for this study?

  • Patients between the ages of 8-12 years with a diagnosis of narcolepsy AND one parent/guardian
  • Participants must be able to understand the purpose of the study

If you would like more information on study requirements, compensation, or eligibility, please call the Neurology Sleep Research team at 617-919-6212 or email us at NeuroSleepResearch-dl@childrens.harvard.edu

Sparkle 1501 Study – POSTPONED

Enrollment for the study is currently on hold due to COVID-19. 

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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Enrollment for the study is currently on hold due to COVID-19. 

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.

If you are living with excessive daytime sleepiness because of narcolepsy with cataplexy, you may want to consider the SPARKLE 1501 Study that is being conducted by a pharmaceutical company.

What is the purpose of the Sparkle 1501 Study?

This clinical study is testing an investigational drug (TAK-994).The main purpose of the study is to look at how safe and tolerable the investigational drug is and how it may affect 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 cataplexy
  • Meet additional requirements as determined by a screening process

 

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

Click here to download their brochure about the study. 

To learn more about the Sparkle 1501 Study and to see if you may qualify, visit www.MyNarcolepsyStudy.com.

Sparkle 2002 Study for IH – POSTPONED

Enrollment for the study is currently on hold due to COVID-19. 

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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Enrollment for the study is currently on hold due to COVID-19. 

People with IH need more options for dealing with the sleepiness that can dominate their lives. Clinical studies are essential components of the research to develop new treatment options, and you may be able to help.

What is the purpose of the Sparkle 2002 Study?

The SPARKLE 2002 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 (IH)
  • First experienced the effects of hypersomnia when you were between 10 and 30 years of age
  • Are willing to stop smoking and give up all nicotine use during the study
  • Are willing to give up all caffeine during the study
  • Meet additional requirements as determined by a screening process

Where do I begin?

The first step involves answering a few questions in an online prescreening questionnaire to see if you are a potential candidate for the study. Depending on your answers, you may be referred to a study clinic for additional screening.

To learn more about the Sparkle 2002 Study and to see if you may qualify, visit www.sparkle2002ih.com.

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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