Sodium Oxybate in Idiopathic Hypersomnia (NCT03597555) | Clinical Trial Compass
CompletedPhase 2/3
Sodium Oxybate in Idiopathic Hypersomnia
France48 participantsStarted 2018-10-18
Plain-language summary
this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cen…
What they're measuring
1
Epworth Sleepiness Scale (ESS) score at the end-point visit