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Sponsored by: |
Orion Corporation, Orion Pharma |
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Information provided by: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT00562198 |
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.
Condition | Intervention | Phase |
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Parkinson´s Disease |
Drug: entacapone and carbidopa Drug: Sinemet 200mg/50mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study. |
Estimated Enrollment: | 16 |
Study Start Date: | January 2008 |
Study Completion Date: | May 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Investigational drug Stalevo 200
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Drug: entacapone and carbidopa
Entacapone 200mg carbidopa 50mg
Drug: Sinemet 200mg/50mg
Sinemet 200mg/50mg once
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Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Oulu University Hospital, Department of Neurology | |
Oulu, Finland, 90220 | |
FinnMedi Tutkimus Oy | |
Tampere, Finland, 33520 | |
Porin Lääkäritalo | |
Pori, Finland, 28100 | |
Helsinki University Hospital, Department of Neurology | |
Helsinki, Finland, 00029 | |
CRST | |
Turku, Finland, 20520 |
Principal Investigator: | Juha Rinne, Dr | Turku PET Centre, Turku, Finland |
Responsible Party: | Orion Pharma ( Irja Korpela ) |
Study ID Numbers: | 2939121 |
Study First Received: | November 19, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00562198 |
Health Authority: | Finland: National Agency for Medicines |
Levodopa Ganglion Cysts Basal Ganglia Diseases Carbidopa Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Entacapone Dopamine Parkinson Disease Movement Disorders Sinemet Raclopride Parkinsonian Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |