current idiopathic hypersomnia (ICSD-3)
Conditions
Interventions
Trade Name: XYREM Sodium Oxybate
Product Name: Sodium Oxybate
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnostic of idiopathic hypersomnia (ICSD-3 criteria) - Age between 18 and 60 years-old - BMI between 18 and 35 kg/m2 - MSLT: mean sleep latency (MSL) of =8 minutes and 90%, total sleep time =6 hours, AHI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Current treatment with modafinil, amphetamine, methylphenidate, mazindol, pitolisant, neuroleptics, hypnotics, barbiturates, antidepressants*, anxiolytic drugs, anticonvulsive therapy, Valproate, budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines, Z-drugs, MAO inhibitors, COMT inhibitors, or sedative antihistamines. If patient has received such therapy, a washout-period of at least 15 days prior to the inclusion in the study is required before starting treatment in this study. *30 days for antidepressants - Succinic semialdehyde dehydrogenase deficiency - Other central nervous system diseases: neurodegenerative diseases, seizure disorders or history of head trauma associated with loss of consciousness - Lifetime history of suicide attempt or suicidal ideation in the past 6 months, prior history of psychotic episodes, Beck depression inventory (BDI) > 16 and/or item G> 0 - 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 - cardiovascular disease compromising the patient’s wellbeing or ability to participate in this study - chronic renal insufficiency - No regular sleep at night: shift work or other continuous non–disease-related life conditions - Participation in another study of an investigational drug within the 28 days prior to Visit 1 or currently - Hypersensitivity to any of the components of the study medication - Pregnancy (ßHCG positive) and breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo ;Secondary Objective: -To evaluate the efficacy of sodium oxybate on excessive daytime sleepiness using MWT latency over 8 weeks compared to placebo -To test the safety issue of sodium oxybate on excessive daytime sleepiness over 10 weeks. age that is applicable;Primary end point(s): ESS score at the end-point visit ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - No residual sleepiness (ESS 3 points) at 8-weeks - Mean sleep latency (minutes) on MWT at 8-weeks - % sleep stages, total sleep time (min), sleep efficiency, microarousal index on polysomnography assessment at 8-weeks - Duration of nighttime sleep (min) at 8-weeks - Clinical global impression change and severity on sleepiness at 8 weeks ( CGI-C and CGI-S) - Life quality and health state at 8-weeks (EQ-5D) - Intensity and duration of sleep inertia (assessed on a visual analog scale from 0 to 10) - Questionnaire on Hyper somnolence severity ;Timepoint(s) of evaluation of this end point: 8 semaines | — |
Countries
France
Contacts
Public ContactTACONNET DECKER
University Hospital of Montpellier
Outcome results
None listed