- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111485
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
March 12, 2024 updated by: Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
36
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marianne Gingras, MSc
- Phone Number: 76142 514-934-1934
- Email: PDsleepresearch@rimuhc.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- McGill University Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
Capsule 250 mg / 50 mg taken at bedtime
Other Names:
Capsule taken at bedtime
Other Names:
|
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
|
Capsule 250 mg / 50 mg taken at bedtime
Other Names:
Capsule taken at bedtime
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Apnea-hypopnea index (AHI)
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 weeks
|
Oxygenation from polysomnography
Time Frame: 2 weeks
|
oxygen desaturation index
|
2 weeks
|
Oxygenation from polysomnography
Time Frame: 2 weeks
|
mean oxygen saturation
|
2 weeks
|
Oxygenation from polysomnography
Time Frame: 2 weeks
|
time with saturation below 90%
|
2 weeks
|
Objective sleep quality from polysomnography
Time Frame: 2 weeks
|
Sleep efficiency
|
2 weeks
|
Objective sleep quality from polysomnography
Time Frame: 2 weeks
|
total sleep time
|
2 weeks
|
Objective sleep quality from polysomnography
Time Frame: 2 weeks
|
wake after sleep onset
|
2 weeks
|
Objective sleep quality from polysomnography
Time Frame: 2 weeks
|
sleep stages distribution
|
2 weeks
|
Objective sleep quality from polysomnography
Time Frame: 2 weeks
|
arousal index
|
2 weeks
|
Subjective sleep quality
Time Frame: 2 weeks
|
Parkinson's Disease Sleep Scale-R
|
2 weeks
|
Daytime sleepiness
Time Frame: 2 weeks
|
Epworth Sleepiness Scale
|
2 weeks
|
Non-motor symptoms
Time Frame: 2 weeks
|
MDS-UPDRS part I
|
2 weeks
|
Cognitive function
Time Frame: 2 weeks
|
Montreal Cognitive Assessment (MoCA)
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marta Kaminska, MD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2017
Primary Completion (Actual)
October 28, 2022
Study Completion (Actual)
October 28, 2022
Study Registration Dates
First Submitted
March 28, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Parkinson Disease
- Apnea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Levodopa
- Carbidopa, levodopa drug combination
Other Study ID Numbers
- MP-37-2017-2573
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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