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.

Who can participate?

You may qualify to participate if you:

  • Are 18–65 years old
  • Have been diagnosed with narcolepsy with or without cataplexy (also known as narcolepsy type 1 or narcolepsy type 2)
  • For patients with narcolepsy with cataplexy, experience 4 or more episodes of cataplexy / week
  • Are willing to stop taking narcolepsy and cataplexy medications during study participation
  • Are willing to stop smoking and give up all nicotine use while you are at the study clinic, including each time you stay overnight
  • Meet additional requirements as determined by a screening process

Where do I begin?

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.

How can I be sure that I understand the study?

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.

What will happen during the screening?

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:

  • Undergo assessments at a screening visit to determine if you qualify to participate in the study
  • Record information in an electronic diary about your sleeping and cataplexy
  • Stop taking medications for narcolepsy and cataplexy before study participation. The study doctor will discuss with you how and when to do this.

What happens if I qualify to participate in the study?

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 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.

Study Treatment

During the Study Treatment Period, you will take your study drug, either TAK-994 or placebo, twice daily, as directed.

Follow-up Period

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

  • You will be reimbursed for all travel needs during study participation
  • You will be compensated for your participation, up to $4,800

The study doctor or staff will discuss this and all other aspects of study participation with you.

What drug is being tested?

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).

Will I receive the investigational drug?

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.

What is a placebo? Why is it used?

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.

What are my responsibilities in the study?

Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:

  • Take medication twice daily and complete a daily diary
  • Follow instructions from the study doctor and staff
  • Ask questions if you have concerns or need clarification about any aspects of the study
  • Complete scheduled assessments
  • Talk with the study doctor BEFORE taking any new medications or supplements
  • Keep your contact information current with study staff

Will I need to make any lifestyle changes?

During the study, you will need to:

  • Refrain from driving
  • Avoid all narcolepsy and cataplexy medications, as well as some additional medications and supplements
  • Avoid certain foods and beverages
  • Avoid strenuous activities

The study doctor will discuss study restrictions and how and when to stop taking your narcolepsy and cataplexy medications during the informed consent process.

Can I leave the study after I start?

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.

Answer a few questions to see if you may qualify for the SPARKLE 1501 Study.

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