Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Christian Baumann; University of Zurich
• Treatments: Sodium Oxybate

Criteria

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 are pregnant or breast feeding,

• Intention to become pregnant during the course of the study,

• Lack of safe contraception, defined as:

Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.

Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the patient,

• Participation in another study with investigational drug within the 30 days preceding and during the present study,

• Previous enrolment into the current study,

• Enrolment of the investigator, his/her family members, employees and other dependent persons,