Back to resultsEffect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
Primary Purpose
Parkinson's Disease, Obstructive Sleep Apnea
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Sinemet CR
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD consistent with the UK Brain Bank;
- Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
- Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study
Exclusion Criteria:
- Other major neurological disorder;
- Already taking long-acting levodopa (at any time of day);
- Taking short-acting levodopa at bedtime or during the night;
- Any contraindication to long-acting levodopa (see below);
- Severe levodopa induced dyskinesias;
- Already on or requiring treatment for restless legs syndrome ;
- Body mass index >35 kg/m2;
- Intercurrent upper respiratory tract infection;
- Other known cause of OSA (e.g. craniofacial malformation);
- 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.
Sites / Locations
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A (drug-placebo)
B (placebo-drug)
Arm Description
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
Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks
Outcomes
Primary Outcome Measures
Apnea-hypopnea index (AHI)
Secondary Outcome Measures
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)
Proportion of patients having adverse events leading to discontinuation of drug
Oxygenation from polysomnography
oxygen desaturation index
Oxygenation from polysomnography
mean oxygen saturation
Oxygenation from polysomnography
time with saturation below 90%
Objective sleep quality from polysomnography
Sleep efficiency
Objective sleep quality from polysomnography
total sleep time
Objective sleep quality from polysomnography
wake after sleep onset
Objective sleep quality from polysomnography
sleep stages distribution
Objective sleep quality from polysomnography
arousal index
Subjective sleep quality
Parkinson's Disease Sleep Scale-R
Daytime sleepiness
Epworth Sleepiness Scale
Non-motor symptoms
MDS-UPDRS part I
Cognitive function
Montreal Cognitive Assessment (MoCA)
Full Information
NCT ID
NCT03111485
First Posted
March 28, 2017
Last Updated
August 22, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Weston Brain Institute
1. Study Identification
Unique Protocol Identification Number
NCT03111485
Brief Title
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
Official Title
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Weston Brain Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A (drug-placebo)
Arm Type
Experimental
Arm Description
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
Arm Title
B (placebo-drug)
Arm Type
Experimental
Arm Description
Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Sinemet CR
Other Intervention Name(s)
Long acting levodopa
Intervention Description
Capsule 250 mg / 50 mg taken at bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Capsule taken at bedtime
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)
Description
Proportion of patients having adverse events leading to discontinuation of drug
Time Frame
2 weeks
Title
Oxygenation from polysomnography
Description
oxygen desaturation index
Time Frame
2 weeks
Title
Oxygenation from polysomnography
Description
mean oxygen saturation
Time Frame
2 weeks
Title
Oxygenation from polysomnography
Description
time with saturation below 90%
Time Frame
2 weeks
Title
Objective sleep quality from polysomnography
Description
Sleep efficiency
Time Frame
2 weeks
Title
Objective sleep quality from polysomnography
Description
total sleep time
Time Frame
2 weeks
Title
Objective sleep quality from polysomnography
Description
wake after sleep onset
Time Frame
2 weeks
Title
Objective sleep quality from polysomnography
Description
sleep stages distribution
Time Frame
2 weeks
Title
Objective sleep quality from polysomnography
Description
arousal index
Time Frame
2 weeks
Title
Subjective sleep quality
Description
Parkinson's Disease Sleep Scale-R
Time Frame
2 weeks
Title
Daytime sleepiness
Description
Epworth Sleepiness Scale
Time Frame
2 weeks
Title
Non-motor symptoms
Description
MDS-UPDRS part I
Time Frame
2 weeks
Title
Cognitive function
Description
Montreal Cognitive Assessment (MoCA)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic PD consistent with the UK Brain Bank;
Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study
Exclusion Criteria:
Other major neurological disorder;
Already taking long-acting levodopa (at any time of day);
Taking short-acting levodopa at bedtime or during the night;
Any contraindication to long-acting levodopa (see below);
Severe levodopa induced dyskinesias;
Already on or requiring treatment for restless legs syndrome ;
Body mass index >35 kg/m2;
Intercurrent upper respiratory tract infection;
Other known cause of OSA (e.g. craniofacial malformation);
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Gingras, MSc
Phone
514-934-1934
Ext
76142
Email
PDsleepresearch@rimuhc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Kaminska, MD, MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
514-934-1934
Ext
76142
Email
PDsleepresearch@rimuhc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
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