Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. (NCT06590662) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
France60 participantsStarted 2024-09-15
Plain-language summary
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).
Who can participate
Age range18 Years – 60 Years
SexALL
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Main inclusion criteria:
* Age between 18 and 60 years-old
* BMI between 18 and 30 kg/m2
* Diagnostic of idiopathic hypersomnia (ICSD-3 criteria) made in the last 5 years, based on Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, showing either: a mean sleep latency (MSL) of ≤8 minutes and \< 2 SOREMPs and/or a 24-h long term polysomnography recording showing total sleep time \>11h/24 hours.
* Apnea-hypopnea index (AHI) \<15/hour, Apnea index \<10/hour, micro-arousals index \<15/hour, Periodic limb movement (PLM) index associated with micro-arousals \<15/hour on the PSG and MSLT performed within the past 5 years.
* Absence of sleep deprivation, assessed by actigraphy or sleep logs for the 7 days preceding study inclusion
* ESS score ≥11 points
* Written informed consent
* National health insurance coverage
* Understand, read and speaks French well
* The participant agrees to follow the contraceptive requirements detailed in the protocol.
Main non-inclusion criteria
* Non-stabilized hypertension
* To be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening, or has positive answers on items number 4 or 5 on the Colombia-Suicide Severity Rating Scale (based on the 6 months before randomization).
* Other psychiatric conditions in the past 6 months
* Presence of other central nervous system diseases: neurodegenerative diseases, seizure disorders, or history of head …