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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590122
• Other study ID #: H-19596
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	PDCMDC 6550 Fannin, Suite 1801	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	first dose of day for each arm