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containing: carbidopa, levodopa, entacapone

Phase 3

Parkinson's Disease | Small molecule | Neurology |Novartis AG|Last Updated: May 17, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment493

FDA Designations

No designations recorded

Clinical trial landscape

containing: carbidopa, levodopa, entacapone · 1 trial · 1 indication

Phase 3 1
NCT00134966A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaParkinson's Disease
COMPLETED493 Analytics
PHASE3COMPLETED
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Symptom control change from baseline to week 39

Secondary Endpoints

Change from baseline to week 39 in activities of daily living
Change from baseline to week 39 in motor function
Change from baseline to week 39 in mental acuity
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)DRUG -
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis * Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity * Parkinson's disease impairment warranting treatment with a levodopa formulation accor...

Countries:United StatesCanadaCzechiaIsraelItalyPolandPortugalTurkey (Türkiye)
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Frequently asked questions about containing: carbidopa, levodopa, entacapone

What is carbidopa, levodopa, and entacapone used for?

Carbidopa, levodopa, and entacapone is a fixed-dose combination therapy being developed for Parkinson's disease. It combines three small molecules in a single capsule: carbidopa 25 mg, levodopa 100 mg, and entacapone 200 mg. It is designed to deliver levodopa replacement therapy along with agents that support its use in Parkinson's disease patients.

Who is developing carbidopa, levodopa, and entacapone?

Novartis AG, which trades under the ticker NVS, is the developer of the fixed-dose carbidopa, levodopa, and entacapone combination. The company sponsored the Phase 3 trial evaluating this capsule formulation in Parkinson's disease.

What phase is carbidopa, levodopa, and entacapone in?

Carbidopa, levodopa, and entacapone is in Phase 3 development. The single registered trial, NCT00134966, is a completed Phase 3 study. The program is investigational and remains in clinical development for Parkinson's disease.

What clinical trial is carbidopa, levodopa, and entacapone in?

Carbidopa, levodopa, and entacapone was studied in NCT00134966, titled "A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa." This completed Phase 3 trial enrolled 493 participants with Parkinson's disease across the United States, Canada, Czechia, Israel, Italy, Poland, Portugal, and Turkey.

How was the Phase 3 trial of carbidopa, levodopa, and entacapone designed?

NCT00134966 was a randomized, double-blind, active-controlled Phase 3 trial comparing fixed-dose carbidopa, levodopa, and entacapone against immediate-release carbidopa/levodopa. It enrolled 493 participants with Parkinson's disease, ages 30 years and older, of all sexes, and did not include healthy volunteers. The study is completed.