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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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 | |
| Helsinki University Hospital, Department of Neurology | |
| Helsinki, Finland, 00029 | |
| Oulu University Hospital, Department of Neurology | |
| Oulu, Finland, 90220 | |
| Porin Lääkäritalo | |
| Pori, Finland, 28100 | |
| FinnMedi Tutkimus Oy | |
| Tampere, Finland, 33520 | |
| CRST | |
| Turku, Finland, 20520 | |
| Principal Investigator: | Juha Rinne, Dr | Turku PET Centre, Turku, Finland |
More Information
| Responsible Party: | Irja Korpela, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT00562198 History of Changes |
| Other Study ID Numbers: | 2939121 |
| Study First Received: | November 19, 2007 |
| Last Updated: | June 12, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Levodopa Carbidopa, levodopa drug combination Entacapone Raclopride Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agonists Adjuvants, Immunologic |