NCT03030599

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

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Subjects will be transitioned to JZP-258 based on their treatment status at study entry. All subjects will begin JZP-258 treatment at the beginning of this period and continue through Week 12. They will be treated with JZP-258 alone for the final two weeks of this 12-week period. Once the JZP-258 dose has been optimized per the Investigator's judgment, these subjects may enter the 2-week Stable-Dose Period with that dose. Subjects are eligible to enter the Double-Blind Randomized-Withdrawal Period if the dose of JZP-258 remains unchanged during the Stable-Dose Period and, in the judgment of the Investigator, no clinically significant worsening in narcolepsy symptoms or clinically significant adverse events due to JZP-258 treatment have occurred. Subjects will return for a Safety Follow-up visit 2 weeks after the Double-Blind Randomized-Withdrawal Period. Subjects who complete the double-blind treatment period during the Main Study are eligible to enter a 24-week Open-Label Extension. During this period subjects will receive open label JZP-258. Subjects will return for a Safety Follow-up visit 2 weeks after the Open-Label Extension Period.

Conditions

• Narcolepsy With Cataplexy

Interventions

Type	Name	Description
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 \[United States Pharmacopeia/ National Formulary\])

Timeline

• Start date: 2017-03-14
• Primary completion: 2019-01-24
• Completion: 2019-07-10
• First posted: 2017-01-25
• Last updated: 2020-11-12
• Results posted: 2020-11-12

Locations

25 sites across 6 countries: United States, Belgium, Czechia, Finland, France, Spain

Regulatory

• FDA-regulated drug study