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Stalevo (Carbidopa / Levodopa / Entacapone) - Summary

 



STALEVO SUMMARY

Stalevo® (carbidopa, levodopa and entacapone) is a combination of carbidopa, levodopa and entacapone for the treatment of Parkinson's disease.

Stalevo® (carbidopa, levodopa and entacapone) is indicated to treat patients with idiopathic Parkinson's disease:

  1. To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered asindividual products.
  2. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION).


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NEWS HIGHLIGHTS

Media Articles Related to Stalevo (Carbidopa / Levodopa / Entacapone)

Findings That Should Speed The Development Of Drugs For Parkinson's Disease
Source: Health News from Medical News Today [2009.11.19]
Australian scientists have significantly advanced our understanding of dopamine release from nerve cells, findings that should speed the development of more effective drugs for treating Parkinson's Disease. People with Parkinson's Disease suffer from muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement.


Progression Of Parkinson's Disease May Be Prevented By Widely Used Cholesterol-Lowering Drug
Source: Statins News From Medical News Today [2009.10.31]
Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson's disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson's disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.

Avian Influenza Strain Primes Brain For Parkinson's Disease
Source: Bird Flu / Avian Flu News From Medical News Today [2009.08.11]
At least one strain of the H5N1 avian influenza virus leaves survivors at significantly increased risk for Parkinson's disease and possibly other neurological problems later in life, according to new research from St. Jude Children's Research Hospital.

Parkinson's Disease
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2009.04.28]
Title: Parkinson's Disease
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 4/28/2009

NC State Researchers Advance Understanding Of Stem Cells
Source: Genetics News From Medical News Today [2009.11.19]
Researchers from North Carolina State University have identified a gene that tells embryonic stem cells in the brain when to stop producing nerve cells called neurons. The research is a significant advance in understanding the development of the nervous system, which is essential to addressing conditions such as Parkinson's disease, Alzheimer's disease and other neurological disorders.

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Published Studies Related to Stalevo (Carbidopa / Levodopa / Entacapone)

Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. [2009.03.15]
The purpose of this study to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study...

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.

Treatment of end-of-dose wearing-off in parkinson's disease: stalevo (levodopa/carbidopa/entacapone) and levodopa/DDCI given in combination with Comtess/Comtan (entacapone) provide equivalent improvements in symptom control superior to that of traditional levodopa/DDCI treatment. [2005]
The aim of this study was to evaluate the efficacy of the new optimised levodopa, Stalevo (levodopa, carbidopa and entacapone) in patients with Parkinson's disease experiencing end-of-dose wearing-off. Treatment with Stalevo was compared to treatment with traditional immediate-release levodopa and dopa-decarboxylase inhibitor (DDCI) formulations along with adjunct entacapone (Comtess/Comtan)...

Levodopa/carbidopa/entacapone in Parkinson's disease. [2009.07]
Levodopa is the most efficacious agent for the treatment of motor features of Parkinson's disease but its chronic use is associated with the development of motor complications. Mounting evidence indicates the short half-life of levodopa and resultant pulsatile stimulation of striatal dopamine receptors leads to wearing off, motor fluctuations and dyskinesias...

[Long term experience with Stalevo in Szeged, Hungary] [2009.05.30]
The triple combination of levodopa, DDCI and entacapone (Stalevo) is used to treat motor complication in patients with Parkinson's disease. In this study we summarized the clinical data of our patients treated with Stalevo for the longest period...

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Clinical Trials Related to Stalevo (Carbidopa / Levodopa / Entacapone)

Study to Evaluate Initiation of Stalevo in Early Wearing-Off [Completed]
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

Stalevo in Early Wearing-Off Patients [Active, not recruiting]
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding [Terminated]
This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet. After the wash-out the study drug on period 2 will be administered according to a crossover design.

Pharmacokinetic Study With Repeated Doses of Stalevo [Completed]
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.

Adherence of Stalevo, Entacapone and Levodopa [Completed]
To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.

To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.

more trials >>

Page last updated: 2009-11-19

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