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.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.

Detailed description

This was a multi-center, double-blind, placebo-controlled, randomized, 3-way crossover study of SEP-363856 that was conducted in adult subjects with narcolepsy-cataplexy. Two oral doses of SEP-363856 (25 and 50 mg QD for 14 days) were administered and compared with matching placebo using a 6-treatment sequence, 3-period, 3-treatment, crossover design.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	SEP363856
DRUG	Placebo

Timeline

• Start date: 2014-06-05
• Primary completion: 2015-05-26
• Completion: 2015-05-26
• First posted: 2021-08-20
• Last updated: 2024-06-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study