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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00590122
First received: December 28, 2007
Last updated: March 12, 2009
Last verified: March 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: b
Parcopa at equivalent dosage to subjects surrent stable dose
Drug: Parcopa
at subjects current stable dose of comparator
Active Comparator: a
carbidopa-levodopa at subjects current stable dose
Drug: carbidopa-levodopa
at subjects current stable dose
Other Name: Sinemet

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William G. Ondo, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00590122     History of Changes
Other Study ID Numbers: H-19596
Study First Received: December 28, 2007
Last Updated: March 12, 2009
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:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014