Clinical Trial 43676

Atlanta, GA 30328


Summary:

A Study to Assess the Frequency and Characteristics of Wake and Sleep State Transitions Over Multiple Nights in Subjects With Narcolepsy Type 1 Compared With Healthy Subject



Criteria:

  • The subject must be judged to be in good health by the investigator to participate in the study, on the basis of clinical evaluations including medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the screening visit.
  • The subject is male or female and aged 16 to 60 years, inclusive, at the time of informed consent. Subjects aged <18 years should have parental assent.
  • The subject has a body mass index (BMI) between ≥18.0 and ≤35.0 kg/m2 at the screening visit.
  • The subject must have regular sleep-wake habits (eg, routinely spending 6.5 to 8.5 hours sleeping nightly, not oversleeping by more than 2 hours on weekends, ie, total sleep not more than approximately 10.5 hours) as determined by investigator interviews and confirmed in accelerometry/actigraphy records obtained between screening and first visit (measured using a minimum of 10 day/night consecutive periods) and who regularly fall asleep between 9:30 PM and 12:00 AM (healthy subjects only).
  • The subject must not require use of sleep aids or must be willing to discontinue use of sleep aids for the duration of the study (see Section 7.3 Excluded Medications for details).
  • If the subject has completed the TAK-994-1501 study, the subject is eligible to enter the current study following the appropriate washout period (60 days).


Qualified Participants May Receive:

Compensation for time and travel for all completed study visits.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.