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

Baylor College of Medicine

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: Parcopa; Drug: carbidopa-levodopa (Sinemet)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00590122

H-19596

Details and patient eligibility

About

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 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.

Enrollment: 20 patients

Sex: All

Ages: 31 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Randomization Group b

Experimental group

Description:

Parcopa at equivalent dosage to subjects current stable dose

Treatment:

Drug: Parcopa

Randomization Group a

Active Comparator group

Description:

Carbidopa-levodopa (Sinemet)at subjects current stable dose

Treatment:

Drug: carbidopa-levodopa (Sinemet)