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).
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.
None
Parallel
Solriamfetol
DrugPatient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. For the experimental arm, the dose will be progressively increased beginning at 75 mg to 300 mg according to tolerance to treatment. Solriamfetol will be taken once a day upon awakening Schema of dispensation 1. One tablet of solriamfetol 75 mg per day for 1 week (week 1) 2. 150 mg of solriamfetol per day for 2 weeks (weeks 2 and 3) 3. According clinical judgment, Dose either maintained stable at 150 mg or increased to 300 mg per day for 2 weeks (weeks 4 and 5). 4. Prescription at week 5: Dose maintained at 150 or 300 mg or reduced at 150 mg per day according to benefit and safety for 2 weeks. Treatment duration: 7 weeks treatment period.
Placebo
DrugPatient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. Placebo will be taken once a day upon awakening Schema of dispensation 1. One tablet of placebo per day for 1 week (week 1) 2. Two tablets of placebo per day for 2 weeks (weeks 2 and 3) 3. According clinical judgment, Either maintained stable with 2 tablets or increased to 4 tablets per day for 2 weeks (weeks 4 and 5). 4. Prescription at week 5: Dose maintained at 2 or 4 tablets or reduced at 2 tablets per day according to benefit and safety for 2 weeks. Treatment duration: 7 weeks placebo period.
Idiopathic hypersomnia severity scale (IHSS) score
IHSS is a tool used to measure the severity of the symptoms experienced by patients with IH during the previous month. The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10-14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and 8 items on a 4-point Likert scale; the Likert scale is a point scale that is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0-50), and higher scores indicate more severe symptoms.
Epworth Sleepiness Scale (ESS) score
ESS is a short 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Maintenance of Wakefulness Test (MWT)
MWT is used in this study to assess an individual's ability to maintain awake while resisting the pressure to fall asleep. Patients will be administrated four 40-minute MWT session at 2 hours interval at baseline visit 2 (Day 14) and at endpoint visit (Day 35), according to validated standard. The changes in MWT will be compared between the treatment groups.
Psychomotor vigilance task (PVT)
PVT is a widely utilized as a measure of behavioral alertness, primary due to its high sensitivity to sleep deprivation and its psychometric advantages over other cognitive tests. The standard 10-min PVT measures sustained or vigilant attention by recording response times (RT) to visual (or auditory) stimuli presented at random inter-stimulus intervals.
Karolinska Sleepiness Scale (KSS)
KSS measures the subjective level of sleepiness at a particular time during the day. On this scale subjects indicate which level best reflects the psycho-physical sate experienced in the last 10 min. The KSS is a measure of situational sleepiness.
24-hour Ambulatory Blood Pressure Monitoring (ABPM)
24-hour ABPM is an accurate, fully automated, and non-invasive method for evaluation of the 24-hour hemodynamic profile of a subject by multiple and regular blood pressure and heart rate measurements. The ABPM will be monitored at baseline and just before the end visit.
Actigraphy to detect the wake and sleep cycle
Actigraphy is a non-invasive test carried out using a device worn on the wrist over a period of one week. It aims to detect the pattern of waking and sleeping.
Pregnancy test (beta HCG blood test)
The dosage taken during a pregnancy test is the beta-HCG dosage. This dosage is carried out from a blood test. It is not necessary to be fasting to take the exam.
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