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Trial record 27 of 27 for:    PDSS2

Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease (PD-Xyrem)

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ClinicalTrials.gov Identifier: NCT02111122
Recruitment Status : Unknown
Verified April 2014 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.


Condition or disease Intervention/treatment Phase
Sleep-wake Disturbances in Motor-phase Parkinson`s Disease Drug: Sodium Oxybate Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
Study Start Date : April 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Oxybate
Treatment (500mg Natrii oxybas/ml) will be administered every day at night time for 6 weeks each orally by the patient itself. If necessary, the investigator will make sure that a relative or caregiver is able to assist in daily treatment administration. The dosage starts at 3g per night and is adapted in steps of 1.5g during visits and telephone screenings and always noted in the "medication log-book". The maximal dosage is 9g per night.
Drug: Sodium Oxybate
Other Name: Brand name: Xyrem

Placebo Comparator: Placebo
Treatment will be administered every day at night time for 6 weeks each orally by the patient itself. If necessary, the investigator will make sure that a relative or caregiver is able to assist in daily treatment administration. As with the active compound, placebo will be given with a starting dose of 3g per night and is adapted in steps of 1.5g during visits and telephone screenings and always noted in the "medication log-book". The maximal dosage is 9g per night.



Primary Outcome Measures :
  1. Objective excessive daytime sleepiness [ Time Frame: after 6 weeks of treatment ]
    mean latencies in the MSLT (multiple sleep latency test)

  2. effect on night-time breathing [ Time Frame: after 6 weeks of treatment ]
    AHI (apnoea/hypopnoea) score on polysomnography


Secondary Outcome Measures :
  1. Motor function [ Time Frame: after 6 weeks of treatment ]
    Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) will be used to assess motor functions in PD in ON & OFF state

  2. Subjective quality of nocturnal sleep [ Time Frame: after 6 weeks of treatment ]
    assessed by the Parkinson's Disease Sleep Scale (PDSS-2) and the REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) in German. Additional questions about the change in symptoms are added to the RBDSQ and PDSS-2

  3. Objective quality of nocturnal sleep including breathing indices [ Time Frame: after 6 weeks of treatment ]
    assessed by overnight Polysomnography (PSG; using the recording system Embla N7000/M-Drive) which includes video monitoring for scoring purposes including eye movements, heart rate, muscle tone, limb movements, nasal airflow, blood oxygen saturation, breathing pattern

  4. Quality of life [ Time Frame: after 6 weeks of treatment ]
    The Parkinson's Disease Questionnaire (PDQ-39) in German will be used to assess quality of life in PD patients

  5. Mood [ Time Frame: after 6 weeks of treatment ]
    The Parkinson's Disease Questionnaire (PDQ-39) in German will be used to assess quality of life in PD patients

  6. Cognition [ Time Frame: after 6 weeks of treatment ]
    The Montreal Cognitive Assessment (MoCA) in German will be used to quantify cognitive function by a fast and established questionnaire which is recommended by the Parkinson Study Group for use in clinical trials

  7. Impulse control [ Time Frame: after 6 weeks of treatment ]
    Impulse control and potential impulsive-compulsive disorders will be assessed by the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) in German

  8. Vigilance [ Time Frame: after 6 weeks of treatment ]
    Vigilance will be assessed by two self-reported questionnaires by the patients, the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS; see appendix). During the MSLT, we will perform the Sustained Attention to Response Test (SART) and the Psychomotor Vigilance Test (PVT) after the first and the third nap.

  9. Subjective Daytime sleepiness [ Time Frame: after 6 weeks of treatment ]
    In addition to the objective EDS measured by the MSLT, subjective sleepiness will be assessed prior to each nap in the course of the MSLT by the Karolinska Sleepiness Scale and the Stanford Sleepiness Scale

  10. Sleep wake rhythm [ Time Frame: after 6 weeks of treatment ]
    Sleep and physical activity levels will be recorded over 14 days by wrist actigraphy (on the non-dominant wrist; light sensor data included, Actiwatch, Respironics) [11]. We will assess the amount of activity, the amount of rest and estimate the number of naps. The recording is starting 14 days before each start of drug administration and 14 days before the end of the respective administration.

  11. Quality of life for caregivers [ Time Frame: after 6 weeks of treatment ]
    Quality of life of partners or caregivers will be assessed by the Zarit Burden of caregiver Interview (ZBCI), which is validated in its german version [12] and for Parkinson patients [13]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111122


Locations
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Switzerland
Department of Neurology Recruiting
Zurich, Switzerland, 8006
Contact: Fabian Büchele, MD    0041-44-255-1111      
Sub-Investigator: Sebastian R Schreglmann, MD         
Sub-Investigator: Fabian Büchele, MD         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Christian R Baumann, MD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02111122     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-0239
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by University of Zurich:
excessive daytime sleepiness
Parkinson`s Disease
sleep-wake disturbances
Sodium Oxybate
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs