DAPHNE (Duodopa in Advanced Parkinson's: Health Outcomes & Net Economic Impact) - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00141518

Purpose

Health economics long-term study

Condition	Intervention	Phase
Advanced Idiopathic Parkinson's Disease	Drug: Levodopa-carbidopa in an intestinal gel formulation Device: CADD-Legacy® 1400	Phase IV

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Secondary Outcome Measures:

Hoehn and Yahr, Schwab and England, MMSE, MADRS, PDQ-39, e-diary [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2010

Arms	Assigned Interventions
1: Experimental	Drug: Levodopa-carbidopa in an intestinal gel formulation should be kept within a range of 0.5-10 ml/hour (1--200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour) Device: CADD-Legacy® 1400 Ambulatory infusion pump

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141518

Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Leslie Kuester )
Study ID Numbers:	S187.4.001, 2005-002654-21
Study First Received:	August 30, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00141518
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Solvay Pharmaceuticals:

Health economics, quality of life

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Quality of Life
Brain Diseases

Neurodegenerative Diseases
Dyskinesias
Dopamine
Parkinson Disease
Movement Disorders
Hyperkinesis
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009