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Sinemet CR for Parkinson's Disease

Phase 4

Waitlist Available

Led By Marta Kaminska, MD, MSc

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will test whether a drug taken at night can improve sleep apnea in patients with Parkinson's disease.

Eligible Conditions

Parkinson's Disease
Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apnea-hypopnea index (AHI)

Secondary outcome measures

Cognitive function

Daytime sleepiness

Non-motor symptoms

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: B (placebo-drug)Experimental Treatment2 Interventions

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 II: A (drug-placebo)Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carbidopa

FDA approved

Placebo oral capsule

2010

Completed Phase 4

~2380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

442 Previous Clinical Trials

159,138 Total Patients Enrolled

Weston Brain InstituteOTHER

11 Previous Clinical Trials

937 Total Patients Enrolled

Marta Kaminska, MD, MScPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

2 Previous Clinical Trials

139 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common indications for Sinemet CR?

"Sinemet CR has been approved to address manganese intoxication, advanced motor fluctuations, and the uncomfortable symptoms associated with restless legs syndrome (RLS)."

Answered by AI

What research has been conducted surrounding the use of Sinemet CR?

"Presently, 16 investigations of Sinemet CR are underway. 4 of these ongoing trials have reached Phase 3 while the remaining 12 studies are in earlier stages. While most experiments are based out of Austin, Texas, 253 distinct sites across the world host clinical research on this medication."

Answered by AI

What are the potential risks associated with Sinemet CR?

"With the drug having already been approved, our team rated Sinemet CR a 3 on safety based off of Phase 4 clinical trials."

Answered by AI

How many individuals have enrolled in the trial thus far?

"Yes, the relevant information hosted on clinicaltrials.gov indicates that this medical trial is currently looking for participants to enrol in the program. This study was first shared online on May 24th 2017 and has been updated as recently as August 22nd 2022; 42 patients are intended to be recruited from a single site."

Answered by AI

Are there any opportunities for volunteer participants in this clinical trial?

"Clinicaltrials.gov confirms that this medical trial is still recruiting participants, with its first post dated May 24th 2017 and the latest update on August 22nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marta Kaminska 2017. "Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03111485.