Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
- Conditions
- Idiopathic Hypersomnia
- Interventions
- Drug: Placebo
- Registration Number
- NCT06590662
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Solriamfetol Solriamfetol Solriamfetol will be taken once a day upon awakening during 7-weeks Placebo Placebo Placebo will be taken once a day upon awakening during 7-weeks
- Primary Outcome Measures
Name Time Method Idiopathic hypersomnia severity scale (IHSS) score From baseline to week 7 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.
- Secondary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) score From baseline to week 7 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) From baseline to week 7 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) From baseline to week 7 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) From baseline to week 7 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.
Sleep inertia questionnaire From baseline to week 7 The Sleep inertia questionnaire evaluated self-reported sleep inertia and sleep drunkenness on the day of the PVT assessment, utilizing wording similar to items from IHSS scale to assess their presence and duration.
Clinical Global Impression Scale for Change (CGI-C) From baseline to week 7 CGI-C was used to measure, the change in excessive daytime sleepiness (EDS) compared to baseline. This scale if administrated by the same investigator and consists of a 7-grade scale as follows: "very much improved", "much improved", "minimally improved", "no change", "minimally worse," "much worse", "very much worse".
Clinical Global Impression Scale for Severity (CGI-S) From baseline to week 7 CGI-S is an observer-rated scale that measures illness severity by using a 7- grade scale ranging from ("normal, not at all ill") "borderline ill", "slightly ill", "moderately ill", "markedly ill", "severely ill", "among the most extremely ill patients".
The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L) From baseline to week 7 EQ-5D-3L is a validated generic quality of life questionnaire that can be completed by the patient and/or caregiver and assesses 5 dimensions: mobility, washing and dressing, daily living activities, discomfort/pain, and anxiety. Each question has 3 response levels: no problem, some problems and important problems. The questionnaire includes also a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Work Productivity and Activity Impairment- General Health (WPAI:GH) From baseline to week 7 WPAI:GH is a well validated instrument to measure the effect of health conditions on work productivity and daily activities. The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS).
Questionnaire on Functional Outcomes of Sleep From baseline to week 7 FOSQ consists of 10 questions related to the effects of fatigue on daily activities. Each item in the FOSQ is rated on a 4 to 6-point scale, where patients provide their level of agreement of frequency of occurrence specific statements to their functioning.
Logbook for compliance to monitor From baseline to week 7 The patient logbook must be completed throughout the treatment to monitor compliance with treatment.
Percentage of sleep stages From baseline to week 7 % of time spent in stage 1 and 2 sleep stages and stage 3 during polysomnography
Microarousal index From baseline to 7 weeks Microarousal index is apneas + hypopneas per hour of sleep during polysomnography assessment. When the respiratory event index (apneas + hypopneas per hour of sleep) is between 5 and 15 per hour of sleep, SAS is considered mild, and between 15 and 30, moderate. Above 30, it is severe.
Total sleep time From baseline to 7 weeks Total sleep time measured in minutes during polysomnography
Trial Locations
- Locations (1)
University Hospital of Montpellier
🇫🇷Montpellier, France