efficacy and tolerance of solriamfetol in patients affected with idiopathic hypersomnia.

Conditions: Idiopathic Hypersomnia

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).


Eligibility criteria:
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 \ 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 trauma associated with loss of consciousness * prior history of psychotic episodes * psychostimulant treatment with modafinil, methylphenidate, mazindol, pitolisant, ongoing or within 15 days prior to visit 1 * treatment for obstructive sleep apnea-hypopnea syndrome ongoing or within 15 days prior to visit 1 * treatment with psychotropic drugs: neuroleptics (i.e. clozapine, olanzapine, aripiprazole, ...), sedative hypnotics (benzodiazepines, zolpidem, zopiclone), central nervous system depressants (barbiturates, ...), antidepressants (ssri (e.g. fluoxetine, sertraline, paroxetine...), serotonin and norepinephrine reuptake inhibitors (srni : e.g. venlafaxine, duloxetine), monoamine oxidase inhibitors), anxiolytic drugs, anticonvulsive therapy (i.e. topiramate, inhibitors of ghb dehydrogenase (i.e. valproate, ethosuximide, phenytoin), or drugs for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives)), ongoing or within 30 days prior to visit 1. * treatment with dopamine antagonist antiemetics except domperidone, catechol-o-methyltransferase (comt) inhibitors, or sedative antihistamines ongoing or within 30 days prior to visit 1 =\> of note, for all the above treatments: if patient has received such therapy, a washout-period of at least 15 days, or equivalent to 5 half-lives of the drug, prior to the inclusion in the study is required before starting treatment in this study. of note, for antidepressants, a washout of at least 30 days should be required. * previously treated with solriamfetol * history of chronic alcohol or drug abuse within the prior 12 months * malignant neoplastic disease requiring therapy within 12 months prior to visit 1 or clinically relevant * heart failure, unstable hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study * renal or hepatic impairment * no regular sleep at night: shift work or other continuous non-disease-related life conditions * has received any other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or plans to use an investigational drug (other than the study intervention) during the study

Keywords: idiopathic hypersomnia solriamfetol polysomnography