Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04573725
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Actual Duration (Months): 19.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorder	Drug: TS-142; Drug: Dose-matched Placebo to TS-142	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder
• Actual Study Start Date: Jul 7, 2017
• Actual Primary Completion Date: Feb 13, 2019
• Actual Study Completion Date: Feb 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5 mg Period in which participants received single-dose of 5 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Experimental: 10 mg Period in which participants received single-dose of 10 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Experimental: 30 mg Period in which participants received single-dose of 30 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Placebo Comparator: Placebo Period in which participants received single placebo prior to bedtime	Drug: Dose-matched Placebo to TS-142; Participants received single dose-matched placebo to TS-142 (oral capsule)

Outcome Measures

Primary Outcome Measures

1. LS mean difference of LPS from placebo [Day 1]

   LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.

2. LS mean difference of WASO from placebo [Day 1]

   WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.

Secondary Outcome Measures

1. LS mean difference of TST from placebo [Day 1]

   TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Outpatients

• Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Patients with a history of any of the following diseases according to the DSM-5 criteria:

1. Hypersomnolence disorder

2. Narcolepsy

3. Breathing-related sleep disorders

4. Circadian rhythm sleep-wake disorder

5. Parasomnias

6. Restless legs syndrome

7. Substance/medication-induced sleep disorder

• Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy

• Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)

• Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder

• Other protocol defined exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Tokyo		Japan

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.

Investigators

• Study Director: Toshiro Heya, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04573725
• Other Study ID Numbers: TS142-201
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 8, 2020