The SPARKLE 1501 Study is testing an investigational drug in people with narcolepsy. 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:
By participating in the SPARKLE 1501 Study, you may be able to:
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:
The study will include:
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 (also known as hypocretin) system in the brain. The orexin system plays a part in regulating wakefulness (keeping people awake).
Participants will be randomly assigned to receive either the investigational drug or a placebo. 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:
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.