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Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-Motor Symptoms in Patients With Idiopathic Parkinson's Disease

2014-08-27 03:31:58 | BioPortfolio

Summary

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on end-of-dose wearing off in persons who have Parkinson's disease.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Parkinson's Disease

Intervention

Carbidopa/levodopa/entacapone, IR carbidopa/levodopa, Carbidopa/levodopa/entacapone, IR carbidopa/levodopa

Location

Xenoscience, Inc
Phoenix
Arizona
United States
85004

Status

Terminated

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:31:58-0400

Clinical Trials [203 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy ...

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With PD Requiring Initiation of Levodopa Therapy

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated...

Pharmacokinetic Study in Healthy Volunteers

The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomised, mul...

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

The purpose of this study is assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combina...

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa comb...

PubMed Articles [65 Associated PubMed Articles listed on BioPortfolio]

Levodopa-carbidopa intestinal gel infusion and weight loss in Parkinson's disease.

Weight loss (WL) is a frequent yet under-recognized complication of levodopa/carbidopa intestinal gel (LCIG) infusion, as well as a milestone of Parkinson disease (PD) disability progression. The comp...

Vitamin B6 deficiency caused by the use of levodopa.

There are indications that the use of levodopa/carbidopa can cause symptomatic vitamin B6 deficiency. However, this has only been described for patients who used the product in the form of an intestin...

A Man Made Manic: Levodopa-Carbidopa-Induced Mania in Traumatic Brain Injury.

Traumatic brain injury (TBI) has had increased notoriety in light of chronic traumatic encephalopathy in professional sports. However, despite the increased rate at which mood disorders affect this po...

Sensor-based algorithmic dosing suggestions for oral administration of levodopa/carbidopa microtablets for Parkinson's disease: a first experience.

Dosing schedules for oral levodopa in advanced stages of Parkinson's disease (PD) require careful tailoring to fit the needs of each patient. This study proposes a dosing algorithm for oral administra...

The effect of continuous levodopa treatment during the afternoon hours.

The aim of this retrospective study was to investigate if patients with PD, who are treated with levodopa-carbidopa intestinal gel (LCIG), clinically worsen during the afternoon hours and if so, to ev...

Medical and Biotech [MESH] Definitions

An inhibitor of DOPA DECARBOXYLASE, preventing conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no antiparkinson actions by itself.

A selective, irreversible inhibitor of Type B monoamine oxidase. It is used in newly diagnosed patients with Parkinson's disease. It may slow progression of the clinical disease and delay the requirement for levodopa therapy. It also may be given with levodopa upon onset of disability. (From AMA Drug Evaluations Annual, 1994, p385) The compound without isomeric designation is Deprenyl.

An inhibitor of DOPA DECARBOXYLASE that does not enter the central nervous system. It is often given with LEVODOPA in the treatment of parkinsonism to prevent the conversion of levodopa to dopamine in the periphery, thereby increasing the amount that reaches the central nervous system and reducing the required dose. It has no antiparkinson actions when given alone.

A deaminated metabolite of LEVODOPA.

A beta-hydroxylated derivative of phenylalanine. The D-form of dihydroxyphenylalanine has less physiologic activity than the L-form and is commonly used experimentally to determine whether the pharmacological effects of LEVODOPA are stereospecific.

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