A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Narcolepsy

Treatments: Drug: Placebo; Drug: TS-091 10mg; Drug: TS-091 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03267303

TS091-1701

JapicCTI-173689 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.

Enrollment: 53 patients

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 3 patient groups, including a placebo group

TS-091 5mg

Experimental group

Treatment:

Drug: TS-091 5mg

TS-091 10mg

Experimental group

Treatment:

Drug: TS-091 10mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo