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

NCT03267303 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TS-091 5mg

Orally taken once daily for 3 weeks

DRUG

TS-091 10mg

Orally taken once daily for 3 weeks

DRUG

Placebo

Orally taken once daily for 3 weeks

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeru Okuyama · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-12-13
Completion
2019-08-08

Countries

  • Japan
  • South Korea

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267303 on ClinicalTrials.gov