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History of Changes for Study: NCT03533114
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Latest version (submitted November 18, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 10, 2018 None (earliest Version on record)
2 June 5, 2018 Outcome Measures and Study Status
3 October 18, 2018 Study Status, Eligibility, Outcome Measures, Arms and Interventions and Contacts/Locations
4 December 5, 2018 Recruitment Status, Study Status and Contacts/Locations
5 February 7, 2019 Study Status and Contacts/Locations
6 April 1, 2019 Contacts/Locations and Study Status
7 May 6, 2019 Study Status and Contacts/Locations
8 July 2, 2019 Study Status and Contacts/Locations
9 August 1, 2019 Study Status and Contacts/Locations
10 September 5, 2019 Contacts/Locations and Study Status
11 October 8, 2019 Study Status and Contacts/Locations
12 December 4, 2019 Study Status and Contacts/Locations
13 January 9, 2020 Study Status and Contacts/Locations
14 January 31, 2020 Contacts/Locations and Study Status
15 April 21, 2020 Recruitment Status, Contacts/Locations, Study Status and Study Design
16 July 31, 2020 Study Status
17 October 7, 2020 Study Status and Study Design
18 October 8, 2020 Study Status
19 December 14, 2020 Study Status
20 February 1, 2021 Recruitment Status and Study Status
21 June 4, 2021 Study Status
22 September 7, 2021
Quality Control Review has not concluded Returned: October 6, 2021
Outcome Measures, Study Status, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, Arms and Interventions and Study Identification
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Results Submission Events
23 November 18, 2021 Study Status, Adverse Events, Outcome Measures, Document Section, Participant Flow and Baseline Characteristics
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Study NCT03533114
Submitted Date:  May 10, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: JZP080-301
Brief Title: A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Official Title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: September 2018
Primary Completion: September 2020 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: May 10, 2018
First Submitted that
Met QC Criteria:
May 10, 2018
First Posted: May 22, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 10, 2018
Last Update Posted: May 22, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Jazz Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Detailed Description:
Open or close this module Conditions
Conditions: Idiopathic Hypersomnia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: JZP-258
JZP-258 at the stable dose and regimen for 2 weeks.
Drug: JZP-258
Subjects randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
Placebo Comparator: Placebo
Placebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks.
Drug: Placebo Oral Tablet
Subjects randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in Epworth Sleepiness Scale (ESS) score
[ Time Frame: 2 Weeks ]

Change in ESS score from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period
Secondary Outcome Measures:
1. Percentage of Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)
[ Time Frame: 2 Weeks ]

Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Randomized Withdrawal Period
2. Change in Maintenance of Wakefulness Test (MWT)
[ Time Frame: 2 Weeks ]

Change in MWT (in minutes) as determined from the first 4 trials of a 40-minute MWT from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period
3. Percentage of Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)
[ Time Frame: 2 Weeks ]

Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Randomized Withdrawal Period
4. Change in Total Score on the FOSQ-10
[ Time Frame: 2 Weeks ]

Change in total score on the FOSQ-10 from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Male or female between 18 and 70 years of age, inclusive, at the time of consent.
  2. Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria.
  3. At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have ESS scores ≥ 11 (as assessed with a look-back period of 1 week).
  4. If currently treated with Xyrem, must have documented clinical improvement of EDS per Investigator's clinical judgment.
  5. Average nightly total sleep time of ≥ 7 hours, per subject history. Total sleep time will be confirmed by Investigator's review of sleep diaries collected during the final 2 weeks of the Screening Period.
  6. If currently treated with stimulants and / or alerting agents or nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose leading up to and throughout the Double-blind Randomized Withdrawal Period.
  7. Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

Exclusion Criteria:

  1. Hypersomnia due to another medical, behavioral, or psychiatric disorder condition.
  2. Evidence of untreated or inadequately treated sleep-disordered breathing.
  3. Clinically significant parasomnias (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
  4. Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Patients with depression under control are allowed per the judgment of the Investigator or the treating physician and the anti-depressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
  5. Current suicidal risk as determined from history by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on C-SSRS, or any history of suicide attempt.
  6. Occupation requiring nighttime shift work or variable shift work with early work start times or other occupations that could affect the safety of the subject per the judgment of the Investigator.
  7. Treatment or planned treatment with benzodiazepines, non-benzodiazepine anxiolytics / hypnotics / sedatives, neuroleptics, opioids, barbiturates, and medications containing valproic acid or its sodium salt (eg, depakene and depakote) within 2 weeks prior to enrollment. Discontinuation for the purpose of this study is permitted only if considered medically appropriate by the Investigator, and subjects must abstain from these medications during the study.
  8. Current or past substance use disorder (including alcohol) according to DSM-5 criteria, or the subject is unwilling to refrain from consuming alcohol, cannabinoids, or prohibited medications during the study.
Open or close this module Contacts/Locations
Central Contact Person: Associate Director Clinical Trial Disclosure
Telephone: 2158323750
Email: ClinicalTrialDisclosure@JazzPharma.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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