NarcolepsyPhase 2NCT03267303
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
A Phase 2 study testing TS-091 5mg and TS-091 10mg in people with Narcolepsy, run by Taisho Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- TS-091 5mg and TS-091 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Oct 2017to 8 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Japan1 site
Taisho Pharmaceutical Co., Ltd selected site
Osaka and Other Japanese City
South Korea1 site
Taisho Pharmaceutical Co., Ltd selected site
Seoul and Other Korean City
About this study
Official title: A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
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
- Narcolepsy
- Being tested
- TS-091 5mg, TS-091 10mg, Placebo
- Keywords
- Narcolepsy
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-091 5mgDrug
Orally taken once daily for 3 weeks
TS-091 10mgDrug
Orally taken once daily for 3 weeks
PlaceboDrug
Orally taken once daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| TS-091 5mg | Experimental | Not described Receives: Drug: TS-091 5mg |
| TS-091 10mg | Experimental | Not described Receives: Drug: TS-091 10mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sleep latency in maintenance of wakefulness test
Measured: 3 weeks
Secondary outcomes (1)
Total score on the epworth sleepiness scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start31 Oct 2017
- Primary completion13 Dec 2018
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Okuyama, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267303
- Sponsor's protocol ID
- TS091-1701
- Other IDs
- JapicCTI-173689
- Status last verified
- Oct 2019
- First submitted
- 28 Aug 2017
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.
PubMed 35193545
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
- ClinicalTrials.gov ID
- NCT03267303
- Acronym / sponsor ID
- TS091-1701
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TS-091 5mg | Experimental | Drug: TS-091 5mg |
| TS-091 10mg | Experimental | Drug: TS-091 10mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-091 5mgOrally taken once daily for 3 weeks | Drug | TS-091 5mg |
| TS-091 10mgOrally taken once daily for 3 weeks | Drug | TS-091 10mg |
| PlaceboOrally taken once daily for 3 weeks | Drug | Placebo |
Primary outcome
Mean sleep latency in maintenance of wakefulness test
Time frame: 3 weeks
1 secondary outcome
Total score on the epworth sleepiness scale
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 35193545Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Okuyama study director
Taisho Pharmaceutical Co., Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TS-091 5mg and TS-091 10mg in people with Narcolepsy, run by Taisho Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sleep latency in maintenance of wakefulness test (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.