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

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03267303
• Collaborator: (none)
• Enrollment: 53
• Locations: 2
• Arms: 3
• Actual Duration (Months): 21.2
• Patients Per Site: 26.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy	Drug: TS-091 5mg; Drug: TS-091 10mg; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy
• Actual Study Start Date: Oct 31, 2017
• Actual Primary Completion Date: Dec 13, 2018
• Actual Study Completion Date: Aug 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TS-091 5mg	Drug: TS-091 5mg; Orally taken once daily for 3 weeks
Experimental: TS-091 10mg	Drug: TS-091 10mg; Orally taken once daily for 3 weeks
Placebo Comparator: Placebo	Drug: Placebo; Orally taken once daily for 3 weeks

Outcome Measures

Primary Outcome Measures

1. Mean sleep latency in maintenance of wakefulness test [3 weeks]

Secondary Outcome Measures

1. Total score on the epworth sleepiness scale [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Osaka And Other Japanese City		Japan
2	Taisho Pharmaceutical Co., Ltd selected site	Seoul And Other Korean City		Korea, Republic of

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.

Investigators

• Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03267303
• Other Study ID Numbers: TS091-1701; JapicCTI-173689
• First Posted: Aug 30, 2017
• Last Update Posted: Oct 11, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taisho Pharmaceutical Co., Ltd.: Narcolepsy
• Additional relevant MeSH terms: Narcolepsy

Study Results

No Results Posted as of Oct 11, 2019