Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease (NCT02111122) | Clinical Trial Compass
CompletedPhase 2
Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
Switzerland16 participantsStarted 2014-04
Plain-language summary
Sleep wake disturbance is a common problem in Parkinson's disease patients and so far the therapeutic possibilities for symptomatic relief are limited. Small, open-label studies indicate that the use of Xyrem (gamma-hydroxybutyrate) might be of benefit in this situation.
This study is intended to show a beneficial effect of the study medication in a randomized cross-over trial, that fulfills strict scientific criteria.
Who can participate
Age range18 Years – 90 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:
* Moderate to severe Parkinson's disease (Hoehn and Yahr II/III) diagnosis according to international criteria \[14\],
* History of disturbed nocturnal sleep and presence of EDS (ESS \>10 points),
* Doses of dopaminergic and other PD treatment must have been stable for at least 14 days prior to the screening visit,
* Negative pregnancy test prior to inclusion (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years),
* Patients are capable of giving informed consent,
* Signed Informed Consent after being informed.
Exclusion Criteria:
Atypical Parkinson disorder, Parkinson's disease without response to levodopa,
* AHI \>15 or oxygen saturation consistently below 90% on baseline polysomnography
* diagnosis of sleep apnoea-syndrome or COPD
* Severe dementia (MoCA\<22),
* Moderate to severe depression (HADS\>15).
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Regular use of CNS depressant substances (opioids, barbiturates) as well as melatonin and other sleep-inducing substances,
* Other clinically significant concomitant disease states (e.g., renal insufficiency (creatinin \> 120 resp. GFR \<40ml/min), hepatic dysfunction (GPT \> 100U/l), severe cardiovascular disease, etc),
* Known or suspected non-compliance, substance or alcohol abuse (i.e. \> 0.5 l wine or 1 l beer per day),
* Homeless persons,
* Women who…