Would you like to participate in a clinical research study for adults who suffer from narcolepsy?
We are inviting you to take part in a clinical research study for adults with narcolepsy. Participation in the Narcolepsy Research Study will include a screening visit, 3 overnight stays in one of our study sites and a follow up day visit. Neither you nor your insurance company will have to pay for the investigational drug or procedures during the study. In addition, participants who complete the study will be compensated up to $749. All meals during your stay at the study site will be provided. The study team can explain more when they contact you. No insurance is required.
The Narcolepsy Research Study is evaluating an investigational drug (also known as the “study drug”) called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy, a sleep disorder that causes daytime drowsiness with or without muscle weakness.
You may qualify for the Narcolepsy Study if you:
- Are 18 to 65 years of age
- Have been diagnosed with narcolepsy with or without cataplexy
About Narcolepsy
Narcolepsy is a long-term neurological disorder that specifically affects the regulation of sleep-wake cycles. The disorder affects both males and females equally, with symptoms often starting in childhood, adolescence, or young adulthood (ages 7 to 25 years). It is estimated that anywhere from 135,000 to 200,000 people in the United States (US) have narcolepsy.1
People with narcolepsy are often misdiagnosed with other conditions, such as psychiatric disorders or medical disorders, delaying proper diagnosis and treatment for years.
The main symptom of narcolepsy is excessive daytime sleepiness.2 Excessive daytime sleepiness is characterized by persistent sleepiness, regardless of nighttime sleep accrual, and is often described as a “sleep attack” where patients experience a sudden and overwhelming sense of sleepiness.1 In between sleep attacks, however, patients with narcolepsy experience normal levels of alertness.
Other symptoms of narcolepsy may include:
- 1. Sudden loss of muscle tone
- 2. Sleep paralysis
- 3. Hallucinations
To treat narcolepsy, a doctor may prescribe stimulants to help keep you alert and awake throughout the day. A doctor may also suggest other medications, like antidepressants, to help manage the condition.
The Narcolepsy Research Study is evaluating an investigational drug (also known as the “study drug”) called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy, a sleep disorder that causes daytime drowsiness with or without muscle weakness.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet. Accessed March 28, 2019
Frequently Asked Questions
What is the purpose of the Narcolepsy Research Study?
The Narcolepsy Research Study is evaluating an investigational drug (also known as the “study drug”) called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy, which means you have a sleep disorder that causes daytime drowsiness with or without muscle weakness. An investigational drug is one that has not been approved by the United States Food and Drug Administration.
The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared with a placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better than taking nothing, and that the study drug is safe.
How long will my participation in this study last?
You will be in this study for up to 7 weeks, and you will need to come to the study center at least 5 times over this period.
What will happen during this study?
The first visit will be a screening visit to a study site in your location, this is referred to as visit 0 and will be a day visit to discuss your eligibility for the study. If you are eligible for the study, and choose to participate, visits 1, 2 and 3 will be treatment visits in which you will receive the study drug and will stay overnight at one of our study sites for a study of your sleep patterns.
Your final visit, visit 5 will be a follow up day visit as a final checkup.
In total there are 5 visits, over a 7-week period. All visits will be at times that are convenient for you and your schedule.
What are the costs?
The study drug will be given at no cost to you, and you or your insurance company will not have to pay for any study doctor visits, laboratory work, tests, or procedures that are needed for the study. No insurance is required.
Will I be paid for being in the study?
Participants who complete the study will be compensated up to $749. All meals during your stay at the study site will be provided. The study team can explain more when they contact you.
What else do I need to consider?
The research team will be able to explain more about what the Narcolepsy Research Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study site?
We match you to a study site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.
About the Narcolepsy Research Study
This study will take place in approximately 50 centers in the United States with about 114 to 171 adults with narcolepsy.
Participants will be in this study for up to 7 weeks, and you will need to come to the study center at least 5 times over this period.
The first visit will be a screening visit to a study site in your location, this is referred to as visit 0 and will be a day visit to discuss your eligibility for the study. If you are eligible for the study, and choose to participate, visits 1, 2 and 3 will be treatment visits in which you will receive the study drug and will stay overnight at one of our study sites for a study of your sleep patterns.
Your final visit, visit 5 will be a follow up day visit as a final checkup.
In total there are 5 visits, over a 7-week period. All visits will be at times that are convenient for you and your schedule.
The study drug will be given at no cost to you, or your insurance company, and you will not have to pay for any study doctor visits, laboratory work, tests, or procedures that are needed for the study. No insurance is required.
Participants who complete the study will be compensated up to $749. All meals during your stay at the study site will be provided. The study team can explain more when they contact you.
What are the Study Requirements?
In order to successfully participate in this study, you must be willing to comply with the following study requirements:
- If you are a sexually active, not surgically sterilized male, you must agree to use a condom in addition to any birth control used by your partner during the study until 1 month after the final dose of the investigational product.
- If you are a woman, you must resist any pregnancy efforts and practice the use of contraceptives such as birth control.
- During the study period, you must not use sedating agents such as hypnotics, tranquilizers, sedating antihistamines, antipsychotics, benzodiazepines, anticonvulsants, clonidine, or antidepressants.
- You must not have pre-planned surgeries that require general anesthesia throughout the course of the study.
- You must have a negative urine drug screen.
- You must agree to remain free of alcohol and illicit drugs through the course of the study.
- You must be willing to complete the study protocol with full compliance with procedures and sign an informed consent form.
Who can take part in the Narcolepsy Research Study?
To be eligible for this study, you must be:
- 18 to 65 years of age
- Diagnosed with narcolepsy with or without cataplexy
- Interested in participating in a narcolepsy clinical research study
All study-related care is provided by Specialist Study Doctors.
Will there be compensation?
Participants who qualify to take part in the study will receive reimbursement for time and travel. Please discuss this with the study team when they contact you.