NCT03030599

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Geographic Reach
6 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 12, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

January 23, 2017

Results QC Date

August 20, 2020

Last Update Submit

November 10, 2020

Conditions

Narcolepsy With Cataplexy

Outcome Measures

Primary Outcomes (1)

  • Change in Weekly Number of Cataplexy Attacks

    Participants completed a daily Cataplexy Frequency Diary each night prior to bedtime. Participants were to record the number of cataplexy attacks that they had each day.

    Change from baseline (2 weeks of the Stable Dose Period) to the 2 weeks of the Double Blind Randomized Withdrawal Period (DB RWP)

Secondary Outcomes (5)

  • Change in the Epworth Sleepiness Scale (ESS) Score

    From the end of the Stable Dose Period to the end of the Double Blind Randomized Withdrawal Period

  • Number of Participants With Worsening Patient Global Impression of Change (PGIc) for Narcolepsy Overall

    At the end of the Double Blind Randomized Withdrawal Period

  • Number of Participants With Worsening Clinical Global Impression of Change (CGIc) for Narcolepsy Overall

    At the end of the Double Blind Randomized Withdrawal Period

  • Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores

    At the End of the Stable Dose Period to the End of the Double Blind Randomized Withdrawal Period

  • Change in 5-level EQ-5D (EQ-5D-5L) Crosswalk Index Score and Visual Analog Scale

    At the End of the Stable Dose Period to the End of the Double Blind Randomized Withdrawal Period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

JZP-258

EXPERIMENTAL

JZP-258

Drug: JZP-258

Interventions

JZP-258DRUG

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

Also known as: Xyrem®
JZP-258
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects between 18 and 70 years of age, inclusive.
  • Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or DSM-5 criteria, and currently untreated or treated with or without anticataplectics.
  • If applicable, treated with a stimulant or alerting agent at unchanged doses for at least 2 months prior to dosing or not treated with a stimulant or alerting agent.
  • Willing and able to comply with the study design schedule and other requirements.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)
  • History or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the subject's safety and/or interfere with the conduct of the study in the opinion of the Investigator.
  • Treatment with any central nervous system sedating agents, including but not limited to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the purpose of study enrollment is permitted only if considered safe by the Investigator and approved by the Medical Monitor).
  • Treatment with an antidepressant for cataplexy, if the withdrawal of the antidepressant during cross-titration with JZP-258 might be unsafe due to prior history of depression.
  • Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

SDS Clinical Trials, Inc.

Orange, California, 92858, United States

Location

Stanford Health Services

Stanford, California, 94305, United States

Location

Colorado Sleep Institute

Boulder, Colorado, 80301, United States

Location

Pulmonary Disease Specialists

Kissimmee, Florida, 34741, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Montefiore/ Sleep-Wake Disorders Center

The Bronx, New York, 10467, United States

Location

Gastonia Medical Specialty Clinic

Gastonia, North Carolina, 94305, United States

Location

Research Carolina

Huntersville, North Carolina, 28078, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

Cleveland Clinic, Sleep Disorder Center

Cleveland, Ohio, 44195, United States

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Fakultni nemocnice Ostrava

Ostrava-Poruba, 70800, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 21, Czechia

Location

Helsingin Uniklinikka, Vitalmed Oy

Helsinki, 00380, Finland

Location

Hôpital Gui de Chauliac

Montpellier, Herault, 34295, France

Location

Hopital Roger Salengro - CHU Lille

Lille, 59037, France

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital General de Castellón

Castelló, 12004, Spain

Location

Instituto de Investigaciones del Sueño

Madrid, 28036, Spain

Location

Hospital Vithas Nuestra Señora de America

Madrid, 28043, Spain

Location

Related Publications (3)

  • Bogan RK, Foldvary-Schaefer N, Skowronski R, Chen A, Thorpy MJ. Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy. CNS Drugs. 2023 Apr;37(4):323-335. doi: 10.1007/s40263-023-00992-y. Epub 2023 Mar 22.

    PMID: 36947322DERIVED

  • Dauvilliers Y, Sonka K, Bogan RK, Partinen M, Del Rio Villegas R, Foldvary-Schaefer N, Skowronski R, Chen A, Black J, Skobieranda F, Thorpy MJ. Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications. CNS Drugs. 2022 Jun;36(6):633-647. doi: 10.1007/s40263-022-00926-0. Epub 2022 May 30.

    PMID: 35635687DERIVED

  • Bogan RK, Thorpy MJ, Dauvilliers Y, Partinen M, Del Rio Villegas R, Foldvary-Schaefer N, Skowronski R, Tang L, Skobieranda F, Sonka K. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Sleep. 2021 Mar 12;44(3):zsaa206. doi: 10.1093/sleep/zsaa206.

    PMID: 33184650DERIVED

MeSH Terms

Conditions

Narcolepsy

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Results Point of Contact

Title
Director, Clinical Trial Disclosure & Transparency
Organization
Jazz Pharmaceuticals
ClinicalTrialDisclosure@JazzPharma.com
2158709177

Study Officials

  • Director Clinical Trial Disclosure & Transparency

    Jazz Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

March 14, 2017

Primary Completion

January 24, 2019

Study Completion

July 10, 2019

Last Updated

November 12, 2020

Results First Posted

November 12, 2020

Record last verified: 2020-11

Locations

CZ(2)FR(2)BE(3)ES(5)US(12)FI(1)