Parkinson's DiseasePhase 4NCT03111485
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
A Phase 4 study testing Sinemet CR in people with Parkinson's Disease and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Obstructive Sleep Apnea
- What is being tested?
- Sinemet CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2017to 28 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease, Obstructive Sleep Apnea
- Being tested
- Sinemet CR, Placebo oral capsule
- Medical subject headings
- Parkinson Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinemet CRDrug
Also called Long acting levodopa
Capsule 250 mg / 50 mg taken at bedtime
Placebo oral capsuleDrug
Also called Placebo
Capsule taken at bedtime
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sinemet CR; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Measured: 2 weeks
Secondary outcomes (13)
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
Measured: 2 weeks
Oxygenation from polysomnography
oxygen desaturation index
Measured: 2 weeks
Oxygenation from polysomnography
mean oxygen saturation
Measured: 2 weeks
Oxygenation from polysomnography
time with saturation below 90%
Measured: 2 weeks
Objective sleep quality from polysomnography
Sleep efficiency
Measured: 2 weeks
Objective sleep quality from polysomnography
total sleep time
Measured: 2 weeks
Objective sleep quality from polysomnography
wake after sleep onset
Measured: 2 weeks
Objective sleep quality from polysomnography
sleep stages distribution
Measured: 2 weeks
Objective sleep quality from polysomnography
arousal index
Measured: 2 weeks
Subjective sleep quality
Parkinson's Disease Sleep Scale-R
Measured: 2 weeks
Daytime sleepiness
Epworth Sleepiness Scale
Measured: 2 weeks
Non-motor symptoms
MDS-UPDRS part I
Measured: 2 weeks
Cognitive function
Montreal Cognitive Assessment (MoCA)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start24 May 2017
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Weston Brain Institute
- Responsible party
- Principal investigator, Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marta Kaminska, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111485
- Sponsor's protocol ID
- MP-37-2017-2573
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03111485
- Acronym / sponsor ID
- MP-37-2017-2573
- Conditions
- Parkinson's Disease, Obstructive Sleep Apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Weston Brain Institute
- Study start
- 24 May 2017 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (drug-placebo) | Experimental | Drug: Sinemet CR, Drug: Placebo oral capsuleSinemet 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) | Experimental | Drug: Sinemet CR, Drug: Placebo oral capsulePlacebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinemet CRAlso: Long acting levodopaCapsule 250 mg / 50 mg taken at bedtime | Drug | A (drug-placebo), B (placebo-drug) |
| Placebo oral capsuleAlso: PlaceboCapsule taken at bedtime | Drug | A (drug-placebo), B (placebo-drug) |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: 2 weeks
13 secondary outcomes
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)
Time frame: 2 weeks
Oxygenation from polysomnography
Time frame: 2 weeks
Oxygenation from polysomnography
Time frame: 2 weeks
Oxygenation from polysomnography
Time frame: 2 weeks
Objective sleep quality from polysomnography
Time frame: 2 weeks
Objective sleep quality from polysomnography
Time frame: 2 weeks
Objective sleep quality from polysomnography
Time frame: 2 weeks
Objective sleep quality from polysomnography
Time frame: 2 weeks
Objective sleep quality from polysomnography
Time frame: 2 weeks
Subjective sleep quality
Time frame: 2 weeks
Daytime sleepiness
Time frame: 2 weeks
Non-motor symptoms
Time frame: 2 weeks
Cognitive function
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Kaminska, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sinemet CR in people with Parkinson's Disease and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.