Study on the Effect of JZP-258 in Patients with Idiopathic Hypersomnia
- Conditions
- Treatment of Idiopathic HypersomniaMedDRA version: 21.1Level: LLTClassification code 10015595Term: Excessive daytime sleepinessSystem Organ Class: 100000004852MedDRA version: 20.0Level: LLTClassification code 10040989Term: Sleep disorder NOSSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-001311-79-IT
- Lead Sponsor
- JAZZ PHARMACEUTICALS INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
•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 International Classification of Sleep Disorders 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 patient with a previous clinical diagnosis of narcolepsy has IH, a screening PSG and MSLT may be performed to confirm the diagnosis of IH, provided there is no history of cataplexy, no history of 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 (eg, 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 EDS after the initiation of Xyrem per Investigator’s clinical judgment.
•Average nightly total sleep time of = 7 hours, per subject history. Average nightly total sleep time will be confirmed by Investigator’s review of sleep diaries collected 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 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.
•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.
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
•Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, 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 one of the following:
b.Apnea Index > 10 on any historical test (unless a subsequent Apnea 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; or
c.Clinically significant hypoventilation; or
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 (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
•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.
•Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on the 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 CNS sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opioids, barbiturates, phenytoin, melatonin, ethosuximide, medications containing valproic acid or its sodium salt (eg, depakene and Depakote), or any other medication in which the subject experiences sedation are prohibited during the study. Treatment must have been discontinued within 2 weeks or 5 half-lives, whichever is longer, prior to enrollment. (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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of JZP-258 in the treatment of IH.;Secondary Objective: The secondary objective of this study is to evaluate the safety of JZP-258 in the treatment of IH;Primary end point(s): ESS, as assessed by the change in ESS from the end of the Stable<br>Dose Period to the end of the Double-blind Randomized Withdrawal Period;Timepoint(s) of evaluation of this end point: at the end of the Stable Dose Period as fixed effects
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key Efficacy Endpoint:<br>Patient Global Impression of change assessed by the proportion of subjects reporting worsening of symptoms (minimally, much or very much) at the end of the Double-blind Randomized Withdrawal Period.<br>Hypersomnolence Severity Scale:Change in total score from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period.<br>Other Secondary Efficacy Endpoints :<br>Clinical Global Impression of change (CGIc): proportion of subjects reported as worse(minimally, much or very much) at the end of the Double-blind Randomized Withdrawal Period<br>FOSQ-10: Change in total score from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period<br>;Timepoint(s) of evaluation of this end point: at the end of Double-blind Randomized Withdrawal Period