Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study

Overview

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.

Full Title of Study: “Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Detailed Description

This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.

Interventions

  • Drug: Parcopa
    • at subjects current stable dose of comparator
  • Drug: carbidopa-levodopa (Sinemet)
    • at subjects current stable dose

Arms, Groups and Cohorts

  • Experimental: Randomization Group b
    • Parcopa at equivalent dosage to subjects current stable dose
  • Active Comparator: Randomization Group a
    • Carbidopa-levodopa (Sinemet)at subjects current stable dose

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of Time in Minutes From When a Patient Was in a Clinical “Off” State, Took Their Medication and Went Into a Clinical “on” State
    • Time Frame: first dose of day for each arm
    • Time to “on” state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 31 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Collaborator
    • UCB Pharma
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joseph Jankovic, Principal Investigator – Baylor College of Medicine
  • Overall Official(s)
    • William G Ondo, MD, Principal Investigator, Baylor College of Medicine

References

Ondo WG, Shinawi L, Moore S. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Mov Disord. 2010 Dec 15;25(16):2724-7. doi: 10.1002/mds.23158.

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