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

NCT03111485 | Completed Phase 4

• 1 other identifier: MP-37-2017-2573
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI)

  2 weeks

Secondary Outcomes (13)

• Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)

  2 weeks

• Oxygenation from polysomnography

  2 weeks

• Oxygenation from polysomnography

  2 weeks

• Oxygenation from polysomnography

  2 weeks

• Objective sleep quality from polysomnography

  2 weeks

Study Arms (2)

A (drug-placebo)

EXPERIMENTAL

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; Drug: Placebo oral capsule

B (placebo-drug)

EXPERIMENTAL

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; Drug: Placebo oral capsule

Interventions

Sinemet CR DRUG

Capsule 250 mg / 50 mg taken at bedtime

Also known as: Long acting levodopa

A (drug-placebo); B (placebo-drug)

Placebo oral capsule DRUG

Capsule taken at bedtime

Also known as: Placebo

A (drug-placebo); B (placebo-drug)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Weston Brain Institute: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Apnea, Obstructive

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Marta Kaminska, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 12, 2017
• Study Start: May 24, 2017
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)