Long-Term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-Severe Dementia Associated With Parkinson's Disease (PDD) - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00623103

Purpose

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
Parkinson's Disease Dementia	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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Dementia Parkinson's Disease Tremor

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Predefined adverse events (AEs) due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Study drug discontinuations due to predefined AEs that are due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III motor examination scores at Weeks 8, 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 8, 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: Yes ]
Change in Mattis Dementia Rating Scale (Mattis DRS-2) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
Change in Ten Point Clock Test (TPCT) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
Change in Neuropsychiatric Inventory-10 (NPI-10) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
Change in UPDRS Part V stage (Modified Hoehn and Yahr Staging)at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria
Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic Parkinson's disease
Mini Mental State Examination score of ≥10 and ≤ 24 (at Screening Visit only)

Exclusion Criteria:

An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations
A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part V)
A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD
A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria
A current diagnosis of a major depressive episode according to DSM-IV criteria
A history of stereotaxic brain surgery for Parkinson's disease
A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623103

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
21st Century Neurology
Phoenix, Arizona, United States, 85004
United States, California
Neurosearch, Inc.
Reseda, California, United States, 91335
Neurosearch II, Inc.
Ventura, California, United States, 93003
United States, Florida
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
Collier Neurologic Specialists
Naples, Florida, United States, 34102
United States, Georgia
Comprehensive Neurology Specialists, PC
Suwanee, Georgia, United States, 30024
United States, Illinois
Evanstan Northwestern Healthcare Medical Group
Glenview, Illinois, United States, 60026
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Ohio
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States, 44302
United States, Pennsylvania
Research Protocol Management Solutions
Pittsburgh, Pennsylvania, United States, 15243
Square 1 Clinical Research
Erie, Pennsylvania, United States, 16506
United States, Texas
Neurology Specialists of Dallas
Dallas, Texas, United States, 75231
United States, Utah
Progressive Clinical Research
Bountiful, Utah, United States, 84010
Argentina
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Buenos Aires, Argentina, C1425CDC
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Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1122AAL
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Rosario, Santa Fe, Argentina, S2000BZL
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Prahran, Victoria, Australia, 3181
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Lille Cedex, France, 59037
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Marseille Cedex, France, 13385
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Dorset, United Kingdom
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Newcastle, United Kingdom, NE4 5PL

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713B2315
Study First Received:	February 14, 2008
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00623103 History of Changes
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