Sodium Oxybate in Idiopathic Hypersomnia

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Pharmaceutical Solutions; Sodium Oxybate

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