A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Condition: Idiopathic Hypersomnia
MeSH terms: Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Intervention: JZP-258; Placebo Oral Solution
Intervention description: Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.; Participants 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between 18 and 75 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
             after the initiation of Xyrem per Investigator's clinical judgment.

          5. 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.

          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 any CNS sedating agents, including but not limited
             to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics,
             sedatives, neuroleptics, opoids, barbiturates, phenytoin, melatonin, ethosuximide,
             medications containing valproic acid or its sodium salt, 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. The Investigator must ensure that discontinuation from these medications
             is medically supervised. 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.