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Trial record 13 of 18 for:    Sinemet® | Recruiting, Not yet recruiting, Available Studies

Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease

This study is currently recruiting participants.
Verified April 2017 by Marta Kaminska, McGill University Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03111485
First Posted: April 12, 2017
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Weston Brain Institute
Information provided by (Responsible Party):
Marta Kaminska, McGill University Health Center
  Purpose
This trial will assess whether long-acting levodopa taken at night improves obstructive sleep apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.

Condition Intervention Phase
Parkinson's Disease Obstructive Sleep Apnea Drug: Sinemet CR Drug: Placebo oral capsule Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Marta Kaminska, McGill University Health Center:

Primary Outcome Measures:
  • Apnea-hypopnea index (AHI) [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability) [ Time Frame: 2 weeks ]
    Proportion of patients having adverse events leading to discontinuation of drug

  • Oxygenation from polysomnography [ Time Frame: 2 weeks ]
    oxygen desaturation index

  • Oxygenation from polysomnography [ Time Frame: 2 weeks ]
    mean oxygen saturation

  • Oxygenation from polysomnography [ Time Frame: 2 weeks ]
    time with saturation below 90%

  • Objective sleep quality from polysomnography [ Time Frame: 2 weeks ]
    Sleep efficiency

  • Objective sleep quality from polysomnography [ Time Frame: 2 weeks ]
    total sleep time

  • Objective sleep quality from polysomnography [ Time Frame: 2 weeks ]
    wake after sleep onset

  • Objective sleep quality from polysomnography [ Time Frame: 2 weeks ]
    sleep stages distribution

  • Objective sleep quality from polysomnography [ Time Frame: 2 weeks ]
    arousal index

  • Subjective sleep quality [ Time Frame: 2 weeks ]
    Parkinson's Disease Sleep Scale-R

  • Daytime sleepiness [ Time Frame: 2 weeks ]
    Epworth Sleepiness Scale

  • Non-motor symptoms [ Time Frame: 2 weeks ]
    MDS-UPDRS part I

  • Cognitive function [ Time Frame: 2 weeks ]
    Montreal Cognitive Assessment (MoCA)


Estimated Enrollment: 42
Study Start Date: December 2016
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (drug-placebo)
Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg) followed by a washout period and placebo oral capsule, each taken at bedtime for 2 weeks
Drug: Sinemet CR
Capsule 250 mg / 50 mg taken at bedtime
Other Name: Long acting levodopa
Drug: Placebo oral capsule
Capsule taken at bedtime
Other Name: Placebo
Experimental: B (placebo-drug)
Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks
Drug: Sinemet CR
Capsule 250 mg / 50 mg taken at bedtime
Other Name: Long acting levodopa
Drug: Placebo oral capsule
Capsule taken at bedtime
Other Name: Placebo

Detailed Description:
Participants with Parkinson's disease and sleep apnea will take long-acting levodopa and placebo at bedtime for 2 weeks each, in a randomized order, with a 2-week washout period in-between. Sleep studies will be done at the end of each period. The primary outcome will be the apnea-hypopnea index change from baseline to on-medication, comparing active medication to placebo. Other outcomes will include other polysomnographic parameters such as oxygenation measures and sleep architecture variables, as well as the Epworth Sleepiness Scale, the Montreal Cognitive Assessment, the Parkinson's disease sleep scale and the Unified Parkinson's Disease Rating Scale. Adverse events will be closely monitored.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of idiopathic PD consistent with the UK Brain Bank;
  2. Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
  3. Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study

Exclusion Criteria:

  1. Other major neurological disorder;
  2. Already taking long-acting levodopa (at any time of day);
  3. Taking short-acting levodopa at bedtime or during the night;
  4. Taking Amantadine, due to vigilance increasing properties;
  5. Taking selegiline after noon, since its metabolites (metamphetamines) may cause sleep disturbances; selegiline will be permitted if taken before noon;
  6. Any contraindication to long-acting levodopa (see below);
  7. Severe levodopa induced dyskinesias;
  8. Already on or requiring treatment for restless legs syndrome ;
  9. Body mass index >35 kg/m2;
  10. Intercurrent upper respiratory tract infection;
  11. Other known cause of OSA (e.g. craniofacial malformation);
  12. Active treatment of OSA (CPAP, dental appliance or other), unless willing to stop treatment 2 weeks prior to start and during the duration of the study.
  Contacts and Locations
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): NCT03111485


Contacts
Contact: Ann Robinson 514-934-1934 ext 36479

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Ann Robinson    514-934-1934 ext 36479    ann.robinson@mail.mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
Weston Brain Institute
Investigators
Principal Investigator: Marta Kaminska McGill University Health Center
  More Information

Responsible Party: Marta Kaminska, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03111485     History of Changes
Other Study ID Numbers: MP-37-2017-2573
First Submitted: March 28, 2017
First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Parkinson Disease
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists