Ongoing Research

Children and adolescents with pediatric narcolepsy and their caregivers can now take part in a patient registry to help researchers and clinicians better understand the condition.  The Children, Adolescents, and their providers: the Narcolepsy Assessment Partnership (CATNAP®) pediatric narcolepsy disease registry collects important health and quality of life information to:

• Better understand pediatric narcolepsy, including the initial diagnosis and natural disease course
• Study ways to improve treatments and outcomes for patients
• Learn more about the impact of narcolepsy on patients and their caregivers

By increasing our knowledge of this life-altering condition, we hope to add valuable scientific insights to the field of pediatric narcolepsy.  Information will be collected through a patient and a clinician portal.

Who can join?

Children and adolescents (under age 18) who have been diagnosed with narcolepsy by a doctor.

Why join a registry?

Taking part in a narcolepsy patient registry will help educate patients and caregivers, inform clinical decision-making, and potentially contribute to the development of new treatment strategies with a better understanding of patient and caregiver impacts.

How can I learn more?

To learn more about participating in this registry, visit the CATNAP® Website

The Brod Group, a science-based health outcomes research group, is conducting telephone interviews on behalf of a pharmaceutical company to help better understand the impact of narcolepsy type 1 from patients’ perspectives.

WHO IS ELIGIBLE?

• Adults aged 18 years and older residing in the US.
• Diagnosed with narcolepsy type 1 (with cataplexy) by a physician and based on the results of a sleep test.

PARTICIPATION DETAILS

• If you are eligible, you will be invited to participate in a telephone interview about how narcolepsy affects you. Participation should take no more than 90-minutes.
• Participants will be asked to use only their first name (or any name of your choice) and to not mention anything that might identify you, like where you live or work.
• As a thank you for completing the telephone interview, we will send you $125.00.

INTERESTED?

If you are interested in participating or have any questions about the study, please call Jane Beck, MLIS, Research Project Manager, with The Brod Group at (415) 317-3987 or email her at jane@thebrodgroup.net.

For market research purposes only. Not for promotional use.

We are inviting you to participate in a research study, which will involve you sitting for an approximately hour-long interview. Your participation is voluntary, and you may stop at any time.

• The purpose of the research study is to understand the benefits and burdens of risk evaluation and mitigation strategy (REMS) programs, which the Food and Drug Administration (FDA) requires manufacturers of certain medications to implement.
• We are asking you to participate because you contacted us as someone who started taking sodium oxybate (Xyrem/Xywav)—a REMS program-covered drug—in the past three years and is interested in taking part in the research study. We obtained your name and contact information from you.
• We are seeking to interview 160 patients as part of this research study. There are no risks associated with participation. Recorded interviews will be kept secure, available only to the study team, and transcriptions of those interviews will be stripped of identifiers. No identifiable information will publicly released.
• If you chose to participate, you will receive a $50 Amazon gift card as a token of appreciation.
• The principal investigator for this study is Ameet Sarpatwari, PhD, JD. Please contact him at asarpatwari@bwh.harvard.edu should you have any questions.
• The research study is being funded by the FDA.
• If you would like to speak to someone not involved in this research study about your rights as a research subject, or any concerns or complaints you may have about the research, contract the Mass General Brigham IRB at 857-282-1900.
• Your information will be kept secure to the extent required by law.
• We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice, and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. Your information will be kept secure to the extent permitted by law.

Narcolepsy is a rare disease that is too often misdiagnosed. It is generally misunderstood by the public and often by many health professionals. Because awareness and understanding remain limited, it is frequently the subject of stereotypes resulting from myths and misconceptions.

TACT created a narcolepsy disease awareness campaign for our client to better inform the public about the disorder. The objectives of the campaign are:
to help the general public, parents, and teachers, recognize the symptoms of narcolepsy and identify the disease more easily;
increase awareness about the realities of the people affected by the disease in order to help reduce the social stigma attached to it.

To support the objectives of the campaign, TACT is organizing individual in-depth interviews to receive input from people living with narcolepsy and to discuss their experiences.

Format: Individual interviews with narcolepsy patients. The Interviews will be of a maximum duration of 1 hour. Participants will be required to answer a short 5-minute survey before the group. Other than this survey and the activity itself, no other commitment is required.

Who is eligible? Any Canadian diagnosed with narcolepsy is eligible. This project is not directly related to any specific product, so all individuals with narcolepsy are eligible.

When? The interviews will go on until mid-August. The exact dates and times will be determined to accommodate participants.

Topic? We will have a discussion about a wide range of topics, such as the journey to a diagnosis, experiences with different medications, thoughts on narcolepsy awareness In Canada and how to improve It, etc.

Compensation? We will offer $40 to participants for the interview.

Confidentiality? All the information shared with the research team will be considered strictly confidential. No third party will have access to any primary material and any report will be anonymized, including the identity of the participants.

If you are interested, please contact Jessica Rousseau at jrousseau@tactconseil.ca.

Register or learn more: https://redcap.link/explain

Pillar Patient Advocates is seeking 370 people living with Narcolepsy to participate in a 30 minute online survey to provide their opinions. They are looking for a mix of those who have never taken an Oxybate such as Xyrem or Xywav AND those who are currently taking an Oxybate. In appreciation of completing the 30 minute survey, participants are paid $50. If interested, please fill out our short registration to be sent the actual survey link once it launches: https://www.research.net/r/ppawakeupnar. This study is for US residents only.

Narcolepsy symptoms in children and adolescents extend beyond sleepiness alone. Narcolepsy symptoms commonly affect academic function, social relationship, mood, and sleep. In order to develop an outcomes scale that reflects values and experiences of kids with pediatric narcolepsy, we are testing a survey among kids 9-17 years with confirmed narcolepsy diagnosis. Participation requires permitting confirmation of diagnosis and completion of online surveys. As a thank you, participants completing surveys will be given a $50 gift card.

For more information about participation, please contact us at NeuroSleepResearch-dl@childrens.harvard.edu or view the flyer by selecting “Link to flyer” on the Boston Children’s Hospital Sleep Center Research & Innovation website.

Better Nights, Better Days is an evidence-based eHealth program to support parents of typically developing children ages 1-10 years old who experience sleeping problems including difficulties falling asleep, staying asleep, and waking too early.

The national team of investigators are conducting this study to understand if Better Nights, Better Days improves the sleep, mental health, wellbeing, and family resiliency in children and parents during the COVID-19 pandemic, and test how to scale-out the Better Nights, Better Days program to support families across Canada.

We are recruiting 1000 families of children who experience sleeping problems to test the clinical effectiveness of Better Nights, Better Days during COVID-19 and evaluate the implementation of the program to scale-out Better Nights, Better Days across Canada. There is no cost for families to participate.  

Inclusion Criteria

• Parent of a child is between the ages of 1 and 10 years old
• Family resides in Canada
• Parent has regular access to high-speed internet and email
• Parent can read, write, and understand English
• Child experiences behavioural sleep difficulties (i.e., problems falling asleep or falling asleep independently; problems following bedtime routines or bedtime resistance; problems staying asleep)

Please share this information with families who you feel may benefit from participating.

This study is being funded by the Canadian Institutes of Health Research (CIHR) Operating Grant: COVID-19 Mental Health & Substance Use Service Needs and Delivery, led by Dr. Penny Corkum (Dalhousie University, IWK Health Centre).

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**

What is the SYMPHONY Study?

The SYMPHONY Study is a clinical research trial currently being conducted at select centers in the US and Canada. The study is for people with narcolepsy who are experiencing excessive daytime sleepiness (EDS) and cataplexy (sudden muscle weakness). The SYMPHONY Study is evaluating AXS-12 (reboxetine) as an investigational oral medication that may improve wakefulness and reduce occurrence of cataplexy.

What is Excessive Daytime Sleepiness (EDS)?

Excessive daytime sleepiness (EDS) is a persistent feeling of sleepiness commonly found in people with narcolepsy. EDS can affect normal sleep-wake cycles, causing people to fall asleep at unexpected times throughout the day.

What is Cataplexy?

Cataplexy is a sudden loss of muscle tone or weakness brought on by strong emotions like laughter, embarrassment, frustration, or surprise. Sometimes there may be mild weakness, such as a drooping of the eyelids. Sometimes the attack could be severe and cause a total body collapse. Cataplexy occurs in 60-70% of people with narcolepsy. While most attacks are brief, some can last several minutes.

Who can participate?

People who are aged 15 to 75 in the U.S. and 25 to 65 in Canada who have narcolepsy and are experiencing cataplexy. Other criteria also apply.

Why Participate?

If you’re living with narcolepsy and cataplexy, the SYMPHONY Study may be right for you. AXS-12, or reboxetine, is being evaluated as an investigational oral medication that may improve wakefulness and reduce occurrence of cataplexy in people living with narcolepsy. If you are qualified to participate:

• You may receive study-related care, study medication and study evaluations at no cost.
• You may also receive compensation for your time and travel.
• You may have the opportunity to help advance potential new treatments for people with narcolepsy. AXS-12 is an investigational oral medication being studied for narcolepsy with cataplexy.

Click here to see if you qualify.

Click here for the Canadian SYMPHONY site.

Please help us improve the clinical trial for patients. Click on this link to a survey and tell us what is important for you when in a clinical trial.

The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age ≥18 years.

This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.

This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or placebo (a tablet that does not contain study drug).

For more information or to find a participating clinical site visit: NCT05156047 or www.intuneihstudy.com

Contact Harmony Biosciences by email at clinicaltrials@harmonybiosciences.com

The POLARIS clinical development program is being conducted by NLS Pharmaceutics. The investigational study drug, Mazindol ER, is a special extended-release (ER) formulation of mazindol and is being tested in this program to evaluate how well it works when given to adult subjects with narcolepsy with or without cataplexy. Additionally, the program is being conducted to determine the drug’s safety, tolerability, and how it is absorbed and processed in the body. A benefit of taking part in this clinical development program is that you and other people with narcolepsy may benefit from the outcome of the POLARIS studies.

Click here to learn more about the program. Click here to view recently announced interim clinical data.

A team of renowned narcolepsy researchers are collaborating to create this narcolepsy registry. By tracking a large number of people with narcolepsy over several years, we will learn more about the experiences of people who have been diagnosed with narcolepsy, the impact the condition has on the lives of those affected, and how the condition changes over time.

The findings from this registry will be published and shared at medical meetings with the hope of stimulating new research and discoveries that can aid in the diagnosis and treatment of narcolepsy.

If you choose to participate in this important project, you will be asked to complete a series of questions every 6 months about yourself, your symptoms, your experience with diagnosis and treatment, as well as your quality of life, productivity and other impacts on your life. Your identity and all of your responses will be completely confidential.

Who can join?
Adults (18 and over) who have been diagnosed with narcolepsy by a doctor.

Why should I join?
To help researchers learn more about narcolepsy and the best ways to manage it.

What do I need to do?
Once you have registered for NEXUS, you will be invited to complete a questionnaire describing your own narcolepsy experience, diagnosis, symptoms and treatment. Participants will be asked to complete follow-up questionnaires every six months.

REGISTER NOW

There is a new clinical trial opportunity for PWNs located in Canada.

To be eligible to participate, you must meet the following criteria:

• Diagnosed with narcolepsy and/or idiopathic hypersomnia
• Age between 18-64
• Living in Canada
• Ability to travel to Montreal
• Have no other sleep disorders
• Have no psychiatric or neurological disorders
• Not pregnant or breastfeeding
• No use of psychotropic drugs
• Eligible for an MRI scan (no pacemaker or metallic prosthesis)

Compensation will be offered for participation. To apply please contact: hypersomnia.research@gmail.com

English Flyer | French Flyer

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 https://narcolepsyclinicalstudy.com/WUN/

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. Participants will have to travel to Montreal.

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