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

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ClinicalTrials.gov Identifier: NCT03111485
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Weston Brain Institute
Information provided by (Responsible Party):
Marta Kaminska, McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Obstructive Sleep Apnea Drug: Sinemet CR Drug: Placebo oral capsule Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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

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

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

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

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

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

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

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

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

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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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. Any contraindication to long-acting levodopa (see below);
  5. Severe levodopa induced dyskinesias;
  6. Already on or requiring treatment for restless legs syndrome ;
  7. Body mass index >35 kg/m2;
  8. Intercurrent upper respiratory tract infection;
  9. Other known cause of OSA (e.g. craniofacial malformation);
  10. 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.

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

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 Posted: April 12, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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