Trial · NCT05015673
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
NCT05015673, Phase 1, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation. Trials, record NCT05015673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05015673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
- NCT number
- NCT05015673
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Narcolepsy
- Interventions
- SEP363856, Placebo
- First posted
- 2021-08-20
- Last updated
- 2024-06-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the total number of cataplexy attacks over the 2-week treatment period as assessed by the cataplexy diary. | Baseline and Week 2 | |
| Primary | Clinical Global Impression-Improvement (CGI-I)at the end of the 2-week treatment period to assess change in narcolepsy-cataplexy symptoms | Week 2 | The CGI-I scale is a standard 7-point scales that requires the clinician and subject, respectively, to assess how much the subject's overall narcolepsy-cataplexy symptoms improved or worsened by the end of the 2-week treatment period compared to baseline. |
| Secondary | Change from baseline in Electromyogram (EDS )at the end of the 2-week treatment period as assessed by the Mean sleep latency (mSL) from the Multiple Sleep Latency Test (MSLT). | Baseline and Week 2 | |
| Secondary | Change from baseline in Excessive day time sleepiness (EDS) at the end of the 2-week treatment period as assessed by the Epworth Sleepiness Scale ( ESS). | Baseline and Week 2 | The ESS is a self-administered questionnaire that provides subjective measure of a subject's general level of daytime sleepiness. The ESS consists of 8 items, which are rated from 0 ("would never doze") to 3 ("high chance of dozing"). |
| Secondary | Change from baseline at Nights 1, 13, 30, and 47 for the following sleep architecture parameters as assessed by Nocturnal polysomnography (NPSG) | Baseline, Night 1, Night 13, Night 30, and Night 47 | * Latency to Rapid Eye Movement (REM) sleep, REM time (total minutes of REM sleep), REM percent (REM time as a percent of Total Sleep Time \[TST\]), and REM density (number of 3-second units per 30-second epoch with at least 1 REM). * Latency to persistent sleep (LPS), TST, wake after sleep onset (WASO), and number of awakenings. * NREM sleep stages N1, N2, and N3 time (total minutes in each stage) and percent (time in each stage as a percent of TST) |
| Secondary | Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline and each postbaseline visit | Week 2 | The C-SSRS is a tool designed to systematically assess and track suicidal adverse events (suicidal behavior and suicidal ideation) |
| Secondary | Treatment-emergent adverse events, serious adverse events, concomitant medications, and change from baseline and results at each postbaseline visit in clinical evaluations | From screening to the end-of-study, an average of 90 days | Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), concomitant medications, and change from baseline and results at each postbaseline visit in clinical evaluations (vital signs, clinical laboratory tests \[hematology, serum chemistry, urinalysis, coagulation panel, and thyroid panel\], and 12-lead ECGs). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37209427 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05015673
GET https://conductscience.org/api/trials/v1/NCT05015673/registered