Narcolepsy
Conditions
Keywords
Narcolepsy
Brief summary
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
Interventions
DRUGTS-091 5mg
Orally taken once daily for 3 weeks
DRUGTS-091 10mg
Orally taken once daily for 3 weeks
DRUGPlacebo
Orally taken once daily for 3 weeks
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria 2. Patients aged ≥16 to \<65 years at the time of obtaining informed consent 3. Outpatients
Exclusion criteria
1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder) 2. Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy 3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema) 4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean sleep latency in maintenance of wakefulness test | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Total score on the epworth sleepiness scale | 3 weeks |
Countries
Japan, South Korea
Outcome results
None listed