A Multicenter, Open-Label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

This study has been completed.

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00139867

Purpose

The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: PARCOPA	Phase III

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa Sinemet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Crossover Assignment
Official Title:	A Multicenter, Open-Label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

Further study details as provided by UCB:

Study Start Date:	January 2004
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Detailed Description:

See approved Package Insert for Adverse Event information.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Stable Parkinson's Disease

Exclusion Criteria:

Not using carbidopa/levodopa tablets

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139867

Locations

United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

Patricia Witt

UCB

More Information

Study ID Numbers:	SP780
Study First Received:	August 29, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00139867
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Levodopa
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Sinemet

Carbidopa
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Antiparkinson Agents
Enzyme Inhibitors
Dopamine Agonists
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009