Clinical trial NCT00590122: Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
time to "on"
delayed on
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2008-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 31
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: first dose of day for each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: PDCMDC 6550 Fannin, Suite 1801
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: William G Ondo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.