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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00623103 |
The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.
Condition | Intervention | Phase |
---|---|---|
Dementia Associated With Parkinson's Disease |
Drug: Rivastigmine capsule Drug: Rivastigmine transdermal patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 76-Week Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD) |
Estimated Enrollment: | 550 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Rivastigmine capsule |
2: Experimental | Drug: Rivastigmine transdermal patch |
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | +41 61 324 1111 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CENA713B2315 |
Study First Received: | February 14, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00623103 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Austria: Agency for Health and Food Safety; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Parkinson's disease dementia cholinesterase inhibitor rivastigmine |
Ganglion Cysts Rivastigmine Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Parkinson Disease Movement Disorders Mental Disorders Parkinsonian Disorders Dementia Delirium |
Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Enzyme Inhibitors Cholinergic Agents Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |