A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03267303 |
Recruitment Status :
Completed
First Posted : August 30, 2017
Last Update Posted : October 11, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy | Drug: TS-091 5mg Drug: TS-091 10mg Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 31, 2017 |
Actual Primary Completion Date : | December 13, 2018 |
Actual Study Completion Date : | August 8, 2019 |

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 |
- Mean sleep latency in maintenance of wakefulness test [ Time Frame: 3 weeks ]
- Total score on the epworth sleepiness scale [ Time Frame: 3 weeks ]

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Ages Eligible for Study: | 16 Years to 64 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
- Patients aged ≥16 to <65 years at the time of obtaining informed consent
- Outpatients
Exclusion Criteria:
- Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
- Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
- Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
- Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267303
Japan | |
Taisho Pharmaceutical Co., Ltd selected site | |
Osaka And Other Japanese City, Japan | |
Korea, Republic of | |
Taisho Pharmaceutical Co., Ltd selected site | |
Seoul And Other Korean City, Korea, Republic of |
Study Director: | Shigeru Okuyama | Taisho Pharmaceutical Co., Ltd. |
Responsible Party: | Taisho Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03267303 |
Other Study ID Numbers: |
TS091-1701 JapicCTI-173689 ( Other Identifier: JapicCTI ) |
First Posted: | August 30, 2017 Key Record Dates |
Last Update Posted: | October 11, 2019 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Narcolepsy |
Narcolepsy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |