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Sinemet CR (Carbidopa / Levodopa) - Summary




SINEMET* CR (Carbidopa-Levodopa) is a sustained-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.

SINEMET CR is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

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Published Studies Related to Sinemet CR (Carbidopa / Levodopa)

Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. [2013]
motor fluctuations... INTERPRETATION: Extended-release carbidopa-levodopa might be a useful treatment

Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. [2010.12.15]
Levodopa use in fluctuating Parkinson's disease (PD) is complicated by an inconsistent and prolonged onset to clinical improvement.This small pilot study did not show significant group differences favoring OD C/L; however, larger studies may be justified, and individual patients may benefit.

Night-time bioavailability of levodopa/carbidopa/entacapone is higher compared to controlled-release levodopa/carbidopa. [2010.11]
OBJECTIVE: Controlled-release levodopa/carbidopa (CR-LC) is often used to provide prolonged control of night-time motor symptoms in patients with Parkinson's disease (PD). Levodopa/carbidopa/entacapone (LCE) provides higher bioavailability of levodopa compared with levodopa/carbidopa formulations and has been shown to be effective in PD patients with wearing-off symptoms. The aim of this study was to compare the bioavailability of levodopa after a single evening dose (administered at 10 p.m.) of LCE 200 or CR-LC 200... CONCLUSIONS: The results of this study demonstrate that a single bedtime dose of LCE 200 provides higher bioavailability of levodopa compared to CR-LC 200.

Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients. [2009.07]
OBJECTIVE: We compared IPX054, a bilayer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily to standard CD/LD given 4 times daily in patients with stable Parkinson disease (PD)... CONCLUSIONS: In stable PD patients, no difference was detected between twice-daily treatment with IPX054 and CD/LD given 4 times daily. In this group, substitution with IPX054 reduced dosing frequency while maintaining CD/LD efficacy. In clinical practice, this ease of administration may offer improved treatment compliance.

Entacapone prolongs the reduction of PLM by levodopa/carbidopa in restless legs syndrome. [2007.11]
OBJECTIVES: Levodopa is effective in the treatment of restless legs syndrome (RLS). However, due to the short duration of action of conventional levodopa/decarboxylase inhibitor formulations, multiple dosing may be required in individual patients with persisting symptoms. We assessed whether a new levodopa formulation containing levodopa, carbidopa, and entacapone (LCE) improves levodopa action in RLS... CONCLUSIONS: Single doses of LCE tablets decreased PLMs in a dose-related manner in RLS patients. Prolonged effects of levodopa on PLMs suggest that, compared with standard levodopa, this new levodopa formulation provides longer symptom control throughout the night in patients with previously untreated RLS.

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Clinical Trials Related to Sinemet CR (Carbidopa / Levodopa)

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet´┐Ż (Levodopa/Carbidopa) [Completed]

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease [Completed]
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet´┐Ż in Parkinson's Disease Subjects [Completed]
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.

An Exploratory Study of XP21279 (With Lodosyn«) and Sinemet« in Parkinson's Disease Subjects [Completed]
The purpose of the study is to assess the pharmacokinetics (PK), pharmacodynamics, and safety of XP21279 sustained release (SR3) formulation [administered with Lodosyn« (carbidopa)] and Sinemet« tablets in subjects with Parkinson's disease with Motor Fluctuations.

Antipsychotic Augmentation With L-Dopa [Recruiting]
Dopamine, a chemical in the brain, has been linked to schizophrenia for a number of years. More recently, there is evidence that certain areas affected in schizophrenia (e. g. motivation, cognition) may reflect too little dopamine, whereas symptoms like hallucinations and delusions have been linked to too much dopamine. This study is designed to evaluate the safety, tolerability, and efficacy of giving L-dopa (Sinemet) to see if it will improve those symptoms related to too little dopamine. L-dopa has been approved for other medical conditions (e. g. Parkinson's disease) and works to increase levels of dopamine. The investigators are linking this study with neuroimaging (fMRI) which will allows us to link any changes the investigators might find in clinical symptoms with changes in the brain. This information can prove useful in better understanding the mechanisms that account for these symptoms, as well as possible new treatments. At present , treatments for these other symptoms that seem important in functional measures of outcome (i. e. deficit symptoms, including amotivation; cognitive symptoms) in schizophrenia have not proven particularly effective. It is hoped that L-dopa may provide a treatment that is more effective; going forward, this information would also be useful in drug development and future lines of investigation. 1. L-dopa will prove effective in improving deficit (also called 'primary negative' e. g. amotivation) and cognitive symptoms in schizophrenia. 2. It will be well tolerated and not increase risk of psychotic symptoms when administered in conjunction with their regular antipsychotic medications.

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Reports of Suspected Sinemet CR (Carbidopa / Levodopa) Side Effects

Drug Ineffective (9)Overdose (6)Adverse Event (6)Parkinson's Disease (4)Product Quality Issue (4)Wrong Technique in Drug Usage Process (3)Fall (3)Abdominal Pain Upper (3)Death (3)Pneumonia Aspiration (2)more >>

Page last updated: 2014-11-30

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