Sodium Oxybate in Idiopathic Hypersomnia (SODHI)
Idiopathic Hypersomnia
About this trial
This is an interventional treatment trial for Idiopathic Hypersomnia focused on measuring Idiopathic Hypersomnia
Eligibility 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) ≤8 minutes and < 2 SOREMPs, AND/OR total sleep time > 11h/24h on 24-hours long-term polysomnography
- Polysomnography recording: sleep efficiency > 85%, total sleep time ≥6 hours, AHI <10/hour, micro-arousals index <15/hour, PLM index associated with micro-arousals <10/hour.
- Absence of sleep deprivation, assessed by actigraphy or sleep logs
- ESS score ≥14 points
- Written informed consent
- National health insurance cover
Exclusion Criteria:
Current alcohol intake or treatment with modafinil, amphetamine, methylphenidate, mazindol, pitolisant, neuroleptics, sedative hypnotics, barbiturates, general anesthetics, myorelaxants, other CNS depressants, antidepressants*, anxiolytic drugs, anticonvulsive therapy, topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), 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, or equivalent to 5 half-lives of the drug, prior to the inclusion in the study is required before starting treatment in this study.
*30 days for antidepressants
- Previous intake of sodium oxybate
- Succinic semialdehyde dehydrogenase deficiency, porphyria
- 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, current or recent history of a major depressive disorder (DSM-V), 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
- Heart failure, severe hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
- Renal or hepatic impairment Compromised respiratory function
- Sleep-related breathing disorders (AHI ≥ 10/h)
- 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 (βHCG positive) and breast-feeding
Sites / Locations
- University Hospital of Montpellier
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Xyrem
Placebos
Xyrem (Sodium Oxybate), oral solution 500mg/mL First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks. First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period. First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal
Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid