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

NCT ID: NCT00590122

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Randomization Group b

Parcopa at equivalent dosage to subjects current stable dose

Group Type: EXPERIMENTAL

Parcopa

Intervention Type: DRUG

at subjects current stable dose of comparator

Randomization Group a

Carbidopa-levodopa (Sinemet)at subjects current stable dose

Group Type: ACTIVE_COMPARATOR

carbidopa-levodopa (Sinemet)

Intervention Type: DRUG

at subjects current stable dose

Interventions

Parcopa

at subjects current stable dose of comparator

Intervention Type: DRUG

carbidopa-levodopa (Sinemet)

at subjects current stable dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Joseph Jankovic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William G Ondo, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

PDCMDC 6550 Fannin, Suite 1801

Houston, Texas, United States

Countries

United States

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.

Reference Type: BACKGROUND

PMID: 20925074 (View on PubMed)

Other Identifiers

H-19596

Identifier Type: -

Identifier Source: org_study_id