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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT02111122
• Date of registration: 08/04/2014
• Prospective Registration: No
• Primary sponsor: Christian Baumann
• Public title: Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease PD-Xyrem
• Scientific title: A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
• Date of first enrolment: April 2014
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02111122
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Christian R Baumann, MD
• Affiliation: University of Zurich

Key inclusion & exclusion 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,



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sleep-wake Disturbances in Motor-phase Parkinson's Disease

Intervention(s)

Drug: Sodium Oxybate

Drug: Placebo

Primary Outcome(s)

effect on night-time breathing [Time Frame: after 6 weeks of treatment]

Objective excessive daytime sleepiness [Time Frame: after 6 weeks of treatment]

Secondary Outcome(s)

Mood [Time Frame: after 6 weeks of treatment]

Objective quality of nocturnal sleep including breathing indices [Time Frame: after 6 weeks of treatment]

Impulse control [Time Frame: after 6 weeks of treatment]

Quality of life for caregivers [Time Frame: after 6 weeks of treatment]

Subjective quality of nocturnal sleep [Time Frame: after 6 weeks of treatment]

Vigilance [Time Frame: after 6 weeks of treatment]

Sleep wake rhythm [Time Frame: after 6 weeks of treatment]

Subjective Daytime sleepiness [Time Frame: after 6 weeks of treatment]

Cognition [Time Frame: after 6 weeks of treatment]

Overall quality of life [Time Frame: after 6 weeks of treatment]

Motor function [Time Frame: after 6 weeks of treatment]

Secondary ID(s)

KEK-ZH-Nr. 2013-0239

Source(s) of Monetary Support

Please refer to primary and secondary sponsors