Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study

This study has been completed.

First Received: December 28, 2007 Last Updated: March 12, 2009 History of Changes

Sponsor:	Baylor College of Medicine
Collaborator:	UCB, Inc.
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00590122

Purpose

To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Parcopa Drug: carbidopa-levodopa	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL

Resource links provided by NLM:

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

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

time to on [ Time Frame: first dose of day for each arm ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2006
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
b: Experimental Parcopa at equivalent dosage to subjects surrent stable dose	Drug: Parcopa at subjects current stable dose of comparator
a: Active Comparator carbidopa-levodopa at subjects current stable dose	Drug: carbidopa-levodopa at subjects current stable dose

Eligibility

Ages Eligible for Study:	31 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
Patients requiring levodopa for their PD
Good subjective response to levodopa
Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
A UPDRS -off- motor score of at least 25
Subjects willing to give informed consent
Subjects who are able and willing to comply with study procedures
If female of child-bearing potential, will use one of the approved birth control measures:
1. Hormonal contraceptives
2. Spermicidal and barrier
3. Intrauterine device
4. Partner sterility

Exclusion Criteria:

Subjects with evidence of significant dementia
Subjects with significant oral lesions
History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
Subjects with poor response to levodopa
Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590122

Locations

United States, Texas
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

UCB, Inc.

Investigators

Principal Investigator:

William G Ondo, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Baylor College of Medicine ( William G. Ondo, MD )
Study ID Numbers:	H-19596
Study First Received:	December 28, 2007
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00590122 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Parkinson's disease
time to "on"
delayed on

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Adjuvants, Immunologic
Central Nervous System Diseases
Antiparkinson Agents

Enzyme Inhibitors
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Sinemet
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009