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Completed Phase 1 Interventional

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.

ClinicalTrials.gov ID: NCT05015673

Public ClinicalTrials.gov record NCT05015673. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 11:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Placebo-controlled, Randomized, 3-period, 3-treatment Crossover Study to Evaluate the Effect of Multiple Oral Dose Administration of SEP-363856 in Male and Female Adult Subjects With Narcolepsy-cataplexy

Study identification

NCT ID
NCT05015673
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
18 participants

Conditions and interventions

Conditions

Interventions

  • SEP363856 Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 4, 2014
Primary completion
May 25, 2015
Completion
May 25, 2015
Last update posted
Jun 25, 2024

2014 – 2015

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
SDS Clinical Trials, Inc. Orange California 92868
Clinical Research Group of St. Petersburg St. Petersburg Florida 33707
NeuroTrials Research Inc. Atlanta Georgia 30342
Duke University Medical Center Durham North Carolina 27710
SleepMed of South Carolina Columbia South Carolina 29201
Todd Swick, MD PA Houston Texas 77063

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05015673, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2024 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05015673 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →