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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR STALEVO 75

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Clinical Trials for Stalevo 75

Trial ID Title Status Sponsor Phase Summary
NCT00099268 Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Orion Corporation, Orion Pharma Phase 3 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 results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00099268 Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Novartis Pharmaceuticals Phase 3 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 results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00125567 Stalevo in Early Wearing-Off Patients Completed Orion Corporation, Orion Pharma Phase 4 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.
NCT00134966 A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa Completed Novartis Phase 3 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 in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
NCT00200447 An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) Completed Molecular NeuroImaging Phase 2 This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.
NCT00462007 Study to Evaluate Initiation of Stalevo in Early Wearing-off Completed Orion Corporation, Orion Pharma Phase 4 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.
NCT00562198 PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding Terminated Orion Corporation, Orion Pharma Phase 2 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Stalevo 75

Condition Name

Condition Name for Stalevo 75
Intervention Trials
Parkinson's Disease 11
Parkinson Disease 2
Idiopathic Parkinson's Disease 1
Sleep Disorders 1
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Condition MeSH

Condition MeSH for Stalevo 75
Intervention Trials
Parkinson Disease 15
Sleep Wake Disorders 1
Parasomnias 1
Narcolepsy 1
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Clinical Trial Locations for Stalevo 75

Trials by Country

Trials by Country for Stalevo 75
Location Trials
United States 37
Italy 11
Canada 11
Finland 7
United Kingdom 7
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Trials by US State

Trials by US State for Stalevo 75
Location Trials
Michigan 3
California 3
Florida 3
Virginia 2
Ohio 2
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Clinical Trial Progress for Stalevo 75

Clinical Trial Phase

Clinical Trial Phase for Stalevo 75
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Stalevo 75
Clinical Trial Phase Trials
Completed 12
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Stalevo 75

Sponsor Name

Sponsor Name for Stalevo 75
Sponsor Trials
Orion Corporation, Orion Pharma 10
Novartis Pharmaceuticals 2
Asan Medical Center 1
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Sponsor Type

Sponsor Type for Stalevo 75
Sponsor Trials
Industry 14
Other 4
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