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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea; Parkinson's Disease
• Interventions: Drug: Sinemet CR; Drug: Placebo oral capsule

• Registration Number: NCT03111485
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Study Start: 2017-05-24
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (drug-placebo)	Sinemet CR	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
A (drug-placebo)	Placebo oral capsule	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
B (placebo-drug)	Sinemet CR	Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks
B (placebo-drug)	Placebo oral capsule	Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)	2 weeks	Proportion of patients having adverse events leading to discontinuation of drug
Oxygenation from polysomnography	2 weeks	time with saturation below 90%
Non-motor symptoms	2 weeks	MDS-UPDRS part I
Objective sleep quality from polysomnography	2 weeks	arousal index
Subjective sleep quality	2 weeks	Parkinson's Disease Sleep Scale-R
Daytime sleepiness	2 weeks	Epworth Sleepiness Scale
Cognitive function	2 weeks	Montreal Cognitive Assessment (MoCA)

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada