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.
About 40 people are expected to participate. You may qualify 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:
Polysomnography Visit and Study Treatment Periods
If the study is right for you, you will come to the study clinic for an overnight sleep test called a polysomnography (PSG) and participate in 2 study treatment periods during a 6-day stay. Each study treatment period will last 2 days. At the beginning of the first study treatment period, a computer will randomly assign you to a study treatment group. Each study treatment group will receive the same infusions but in a different order.
All study participants will receive a total of 2 infusions, 1 each of the following:
On Day 1 (Study Treatment Period 1), you will receive your first infusion of TAK-925 or placebo. During the 9-hour infusion, you will have 4 maintenance of wakefulness tests (MWTs), each lasting 40 minutes, to see how long you can stay awake. These tests will use the same equipment as the PSG. You will be asked to stay awake in between these tests as much as you can.
On Day 2, you will not receive any infusions. This day is known as a washout period. You will repeat this cycle for the second study treatment period, with an infusion on Day 3 and washout period on Day 4.
You will be contacted by phone for a check of your health about 7 days after leaving the study clinic on Day 4. All women of childbearing potential will need to return to the clinic for a urine pregnancy test. You may be asked to come to the study clinic for any safety issues or concerns.
Reimbursement and Compensation
You will be reimbursed for your time and travel. You may also be eligible to receive compensation for participating in and/or completing the study. The study doctor or staff will discuss this and all other aspects of study participation with you.
TAK-925 is designed to turn on the orexin system in the brain. The orexin system plays a part in wakefulness (keeping people awake). TAK-925 will be given by intravenous infusion. A needle will be used to insert a thin, flexible tube (catheter) into one of your veins, usually in your arm. You will receive the study drug through this catheter.
Yes. All study participants will receive 1 infusion of the investigational drug (TAK-925) and 1 infusion of the placebo, which does not contain any active drug.
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.