Narcolepsy Type 1
Conditions
Interventions
Trial Group:Oral administration TAK-360
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to understand and fully comply with trial procedures and requirements; 2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial; 3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures;
Exclusion criteria
Exclusion criteria: 1. Participant has a positive pregnancy test or is lactating/breastfeeding; 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS); 3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS); 4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs; 5. Participant has developed a new history of seizures; 6. Participant has experienced clinically significant head injury, per investigator opinion; 7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage; 8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure; 9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder; 10. Participant has developed a history of cancer in the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of at least 1 treatment-emergent adverse event (TEAE) during the trial.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in WCR;Change from baseline in mean sleep latency on the MWT;Change from baseline on the NSS-CT (NT1 only) or NSS-2-CT (NT2 only);Change from baseline in IHSS total score;Change from baseline in ESS total score; | — |
Countries
China
Contacts
Public ContactShuqin Zhan
Xuanwu Hospital Capital Medical University
Outcome results
None listed