A Phase 2 interventional study of Solriamfetol and Placebo in Idiopathic Hypersomnia, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
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).
173 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 133 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main inclusion criteria:
Main non-inclusion criteria
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.
Solriamfetol will be taken once a day upon awakening during 7-weeks
Drug: Solriamfetol
Placebo will be taken once a day upon awakening during 7-weeks
Drug: Placebo
Patient 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.
Patient 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.
Time frame: From baseline to week 7
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.
Time frame: From baseline to week 7
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.
Time frame: From baseline to week 7
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.
Time frame: From baseline to week 7
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.
Time frame: From baseline to week 7
Sleep inertia questionnaire
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.
Time frame: From baseline to week 7
Clinical Global Impression Scale for Change (CGI-C)
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".
Time frame: From baseline to week 7
Clinical Global Impression Scale for Severity (CGI-S)
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".
Time frame: From baseline to week 7
The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L)
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).
Time frame: From baseline to week 7
Work Productivity and Activity Impairment- General Health (WPAI:GH)
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).
Time frame: From baseline to week 7
Questionnaire on Functional Outcomes of Sleep
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.
Time frame: From baseline to week 7
Logbook for compliance to monitor
The patient logbook must be completed throughout the treatment to monitor compliance with treatment.
Time frame: From baseline to week 7
Percentage of sleep stages
% of time spent in stage 1 and 2 sleep stages and stage 3 during polysomnography
Time frame: From baseline to week 7
Microarousal index
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.
Time frame: From baseline to 7 weeks
Total sleep time
Total sleep time measured in minutes during polysomnography
Time frame: From baseline to 7 weeks
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.
Time frame: From baseline to week 8
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.
Time frame: From 1 week before baseline to 1 week before week 7
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.
Time frame: 90 days before baseline
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Disorders of Excessive Somnolence→
University Hospital, Montpellier