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| Sponsor: | Orion Corporation, Orion Pharma |
|---|---|
| Information provided by: | Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT00562198 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Investigational drug Stalevo 200
|
Drug: entacapone and carbidopa
Entacapone 200mg carbidopa 50mg
Drug: Sinemet 200mg/50mg
Sinemet 200mg/50mg once
|
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Neurotransmitter Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Basal Ganglia Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Dopamine Agonists Neurodegenerative Diseases Brain Diseases Movement Disorders Therapeutic Uses Tranquilizing Agents Carbidopa |
Nervous System Diseases Adjuvants, Immunologic Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Enzyme Inhibitors Antipsychotic Agents Pharmacologic Actions Entacapone Parkinson Disease Sinemet Raclopride Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |