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A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

NCT03030599 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2020-11-12

Study results available
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Summary

This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.

Conditions

  • Narcolepsy With Cataplexy

Interventions

DRUG

JZP-258

JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate

OTHER

Placebo

Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial \[United States Pharmacopeia/ National Formulary\])

Sponsors & Collaborators

Principal Investigators

  • Director Clinical Trial Disclosure & Transparency · Jazz Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2019-01-24
Completion
2019-07-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Finland
  • France
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03030599 on ClinicalTrials.gov