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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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