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

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: carbidopa-levodopa (Sinemet); Drug: Parcopa

• Registration Number: NCT00590122
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Results First Submitted: 2017-08-22
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Results First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomization Group a	carbidopa-levodopa (Sinemet)	Carbidopa-levodopa (Sinemet)at subjects current stable dose
Randomization Group b	Parcopa	Parcopa at equivalent dosage to subjects current stable dose

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

PDCMDC 6550 Fannin, Suite 1801; 🇺🇸 Houston, Texas, United States