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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Sinemet CR

Intervention Type DRUG

Capsule 250 mg / 50 mg taken at bedtime

Placebo oral capsule

Intervention Type DRUG

Capsule taken at bedtime

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

Group Type EXPERIMENTAL

Sinemet CR

Intervention Type DRUG

Capsule 250 mg / 50 mg taken at bedtime

Placebo oral capsule

Intervention Type DRUG

Capsule taken at bedtime

Interventions

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Sinemet CR

Capsule 250 mg / 50 mg taken at bedtime

Intervention Type DRUG

Placebo oral capsule

Capsule taken at bedtime

Intervention Type DRUG

Other Intervention Names

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Long acting levodopa Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No