Study on the Effect of JZP-258 in Patients with Idiopathic Hypersomnia

Phase 1

• Conditions: Treatment of Idiopathic Hypersomnia; MedDRA version: 20.0Level: LLTClassification code 10040989Term: Sleep disorder NOSSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10015595Term: Excessive daytime sleepinessSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-001311-79-CZ
• Lead Sponsor: Jazz Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-13
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•Male or female between 18 and 75 years of age, inclusive, at the time of consent.
•Have a primary diagnosis of IH according to the ICSD-2 or ICSD-3 criteria. If documentation of diagnosis of IH is unavailable or the Investigator deems it necessary to confirm diagnosis, diagnostic testing will be conducted during the Screening Period to confirm the diagnosis of IH according to ICSD-3 criteria. If the Investigator suspects a subject with a previous clinical diagnosis of narcolepsy has IH, a screening polysomnogram (PSG) and multiple sleep latency test (MSLT) may be performed to confirm the diagnosis of IH, provided there is no history of cataplexy, no history of sleep onset rapid eye movement periods (SOREMP) on nocturnal PSG, and no history of =2 SOREMPs on MSLT.
•At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have Epworth Sleepiness Scale (ESS) scores = 11 (as assessed with a look-back period of 1 week). Any subject who will wash out of medications during the Screening Period that could impact ESS score at Screening (e.g., stimulant, alerting agent when not taken at a stable dose) will only have to meet the ESS score = 11 requirement at the Baseline visit, after they have washed out of their medication.
•If currently treated with Xyrem, must have documented clinical improvement of excessive daytime sleepiness (EDS) after the initiation of Xyrem per Investigator’s clinical judgment.
•Average nightly total sleep time (TST) of = 7 hours, per subject history. Average nightly TST will be confirmed by sleep diaries completed by subjects during the final 2 weeks of the Screening Period.
•If currently treated with stimulants and/or alerting agents or nicotine replacement therapy, must have been taking the same dosing regimen 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.
•Females must be either: postmenopausal defined as no menses for =12 months without an alternative cause or surgically sterile, or a woman of childbearing potential who has used a highly effective contraceptive measure for at least 2 months prior to the first dose of study drug and consents to use a highly effective contraceptive measure from the first dose of study drug, through 30 days after the last dose of study drug. Male subjects who have not had a vasectomy and who are sexually active with a female partner of childbearing potential must consent to using condoms with their partner from Day 1 through 30 days after the last dose of study drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

•Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (e.g., narcolepsy, multiple sclerosis, Parkinson’s disease, stroke).
•Evidence of untreated or inadequately treated sleep-disordered breathing including:
a.Presence of clinically significant and untreated obstructive or central sleep apnea as determined by the Investigator or documented previously
or documentation of 1 of the following:
b.Apnea Index ( >10) on any historical test (unless a subsequent apneal index= 10 was reported after treatment), and the subject agrees to use this treatment throughout the duration of the study) or during the Screening PSG (if done) while on obstructive sleep apnea treatment or untreated
c.Clinically significant hypoventilation
d.Noncompliance with primary obstructive sleep apnea therapy (compliance defined as positive airway pressure use of =4 hours per night on =70% of nights [=5 of 7 nights / week], historical report [with Investigator concurrence] of use of an oral appliance on =70% of nights [=5 of 7 nights/week], or receipt of an effective surgical intervention for obstructive sleep apnea symptoms)
•Clinically significant parasomnias (e.g., sleep walking, rapid eye movement [REM] sleep behavior disorder, etc.).
•Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Subjects with depression under control are allowed per the judgment of the Investigator or the treating physician and the antidepressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
•Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item No.4 or No.5 on the Columbia Suicide Severity Rating Scale (C-SSRS), or any history of suicide attempt.
•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.
•Treatment or planned treatment with any central nervous system (CNS) sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, medications containing valproic acid or its sodium salt (e.g., depakene and Depakote™), or other sedating antiseizure medications, melatonin, muscle relaxants, general anesthetics, or any other medication in which the subject experiences sedation are prohibited during the study. Treatment must have been discontinued for at least 2 weeks or 5 half-lives prior to enrollment (whichever is longer). Discontinuation for the purpose of study enrollment is permitted only if considered safe and medically appropriate by the Investigator, and approved by the Medical Monitor. The Investigator must ensure that discontinuation from these medications is medically supervised. Subjects must abstain from these medications during the study.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified