NCT02111122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

April 8, 2014

Last Update Submit

January 21, 2021

Conditions

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

Keywords

excessive daytime sleepinessParkinson's Diseasesleep-wake disturbancesSodium Oxybate

Outcome Measures

Primary Outcomes (2)

  • Objective excessive daytime sleepiness

    mean latencies in the MSLT (multiple sleep latency test)

    after 6 weeks of treatment

  • effect on night-time breathing

    AHI (apnoea/hypopnoea) score on polysomnography

    after 6 weeks of treatment

Secondary Outcomes (11)

  • Motor function

    after 6 weeks of treatment

  • Subjective quality of nocturnal sleep

    after 6 weeks of treatment

  • Objective quality of nocturnal sleep including breathing indices

    after 6 weeks of treatment

  • Overall quality of life

    after 6 weeks of treatment

  • Mood

    after 6 weeks of treatment

  • +6 more secondary outcomes

Study Arms (2)

Sodium Oxybate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Sodium OxybateDRUG
Also known as: Brand name: Xyrem
Sodium Oxybate
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • Patients are capable of giving informed consent,
  • Signed Informed Consent after being informed.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Zurich, 8006, Switzerland

Location

Related Publications (1)

  • Buchele F, Hackius M, Schreglmann SR, Omlor W, Werth E, Maric A, Imbach LL, Hagele-Link S, Waldvogel D, Baumann CR. Sodium Oxybate for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Jan 1;75(1):114-118. doi: 10.1001/jamaneurol.2017.3171.

    PMID: 29114733DERIVED

MeSH Terms

Conditions

Disorders of Excessive SomnolenceParkinson Disease

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Officials

  • Christian R Baumann, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor dr. med.

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

August 1, 2016

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

CH(1)