The SPARKLE 1501 Study is testing an investigational drug in people with narcolepsy with cataplexy. 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.
You may qualify to participate if you:
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.
You will review the informed consent form with the study doctor or staff. You should ask as many questions as needed to make sure you understand what will happen during your study participation. If your questions and concerns are fully addressed and you understand all aspects of the study and want to continue to the additional screening, you will need to sign the consent form. Throughout your study participation, you should talk to the study doctor or staff when you have questions or concerns about any aspects of the study.
The study doctor and staff will assess your qualifications for participation. You will be asked about your medical history, treatments and medications, and other issues that may affect your ability to participate in the study. You will also need to:
Sleep Studies and Inpatient Clinic Stays
If the study is right for you, you will come to the study clinic for 3 separate inpatient clinic stays. On the first day of each inpatient stay, you will have an overnight sleep test called a polysomnography (PSG) to check for other sleep disorders, low levels of oxygen in your blood, pauses in your breathing, and overly shallow breathing.
You will have baseline tests at your first inpatient clinic stay before beginning the 28-day Study Treatment Period. At the next 2 inpatient clinic stays, the study doctor and staff will perform assessments and procedures to monitor your health and any changes from baseline test results.
Clinic Visits (Outpatient)
You will have 2 additional clinic visits that will not require an overnight stay. These visits will allow the study doctor and staff to monitor your health between inpatient clinic stays. Although these visits will not require an overnight stay, you may have the option to stay at the inpatient clinic the night before the visits.
During the 28-day Study Treatment Period, you will take your study drug, either TAK-994 or placebo, twice daily, as directed.
You will have a final clinic visit about 7 days after you take your last dose of study drug at the end of the third inpatient stay.
Travel Support and Compensation
The study doctor or staff will discuss this and all other aspects of study participation with you.
The investigational drug is called TAK-994. It is designed to turn on the orexin system in the brain. The orexin system plays a part in regulating wakefulness (keeping people awake).
Two-thirds (about 67%) of study participants will receive the investigational drug. The other third (about 33%) will receive a placebo. You will be assigned one of these two study treatments by chance. Neither you nor the study doctor or staff will know which study treatment you receive.
A placebo looks like the investigational drug but contains no active ingredients. Placebos are often used in clinical research studies to help evaluate the investigational drug by comparing effects seen in study participants who take the investigational drug to effects seen in those who take the placebo.
Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:
During the study, you will need to avoid:
The study doctor will discuss study restrictions with you during the informed consent process.
You can stop taking part in this study at any time. If you choose not to take part or you agree to take part but then withdraw, medical care you receive outside the study will not be affected. The study doctor will discuss other treatment options with you.