Clinical Trial 43866

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 Subjects Using a Portable Electroencephalogram Device


Criteria:


1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject has access to at-home Wi-Fi and can add an internet-ready device with assistance.
3. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization before the initiation of any study procedures.
4. 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.
5. 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.
6. The subject has a body mass index (BMI) between ≥18.0 and ≤35.0 kg/m2 at the screening visit.
7. 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).
8. 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).
9. 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). Subjects With NT1 Only:
10. A subject with NT1 who is drug-naïve may also be enrolled.
11. A subject with NT1 must present with subjective sleep complaint.
12. A subject with NT1 must have a diagnosis of NT1, as defined by the ICSD-3 criteria
13. A subject with NT1 must be HLA-DQB1*06:02 positive, as defined by prior history or by a test at screening.
14. A subject taking medication to control cataplexy must be on stable treatment for at least 5 weeks (35 days). Subjects should not discontinue cataplexy medication for this study. 7.2

Exclusion Criteria:
Any subject who meets any of the following criteria will not qualify for entry into the study: All Subjects
1. The subject has participated in an investigational drug study within 60 days (or based on local regulations) before the screening visit. The 60-day window will be derived from the date of the last study procedure and/or adverse event (AE) related to the study procedure in the previous study to the screening visit of the current study.
2. The subject is an employee of the sponsor or study site or an immediate family member (eg, spouse, parent, child, sibling) of an employee of the sponsor or study site.
3. The subject has a current diagnosis of cancer except for squamous or basal cell skin cancer.
4. The subject has a nicotine or marijuana dependence that is likely to have an effect on sleep (eg, a subject who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study.
5. The subject has a positive alcohol test at screening and is unwilling to refrain from alcohol use from screening to the end of the study.
6. The subject cannot maintain stable sleep environment at home, for example, due to young children not yet sleeping through the night or partners with disrupted sleep (eg, shift workers).
7. The subject is undergoing current treatment for hepatitis B with interferon.
8. The subject had major surgery within 4 weeks before the screening visit.
9. The subject has a current or prior history of substance use disorder (SUD)—moderate severity or severe SUD corresponding to substance dependence, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria.
10. The subject has a risk of suicide according to endorsement of Item 4 or 5 of the screening visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
11. The subject has medical condition, such as past or current epilepsy, seizure, head injury/trauma, medically significant unstable cardiovascular, pulmonary, hepatic, renal, or gastrointestinal disease, that interferes with a normal sleep pattern or would preclude enrollment in the view of the investigator.
12. The subject has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.


Qualified Participants May Receive:

Will 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.