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

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573725
• Other study ID #: TS142-201
• Status: Completed
• Phase: Phase 2
• Start date: July 7, 2017
• Est. completion date: February 13, 2019

Study information

• Verified date: October 2020
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• TS-142
Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
• Dose-matched Placebo to TS-142
Participants received single dose-matched placebo to TS-142 (oral capsule)

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LS mean difference of LPS from placebo	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.	Day 1
Primary	LS mean difference of WASO from placebo	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.	Day 1
Secondary	LS mean difference of TST from placebo	TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.	Day 1