NCT00590122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
14.4 years until next milestone

Results Posted

Study results publicly available

March 14, 2023

Completed
Last Updated

March 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

December 28, 2007

Results QC Date

August 22, 2017

Last Update Submit

February 16, 2023

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasetime to "on"delayed on

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Randomization Group b

EXPERIMENTAL

Parcopa at equivalent dosage to subjects current stable dose

Drug: Parcopa

Randomization Group a

ACTIVE COMPARATOR

Carbidopa-levodopa (Sinemet)at subjects current stable dose

Drug: carbidopa-levodopa (Sinemet)

Interventions

ParcopaDRUG

at subjects current stable dose of comparator

Randomization Group b
carbidopa-levodopa (Sinemet)DRUG

at subjects current stable dose

Randomization Group a

Eligibility Criteria

Age31 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Hormonal contraceptives
  • Spermicidal and barrier
  • Intrauterine device
  • Partner sterility

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PDCMDC 6550 Fannin, Suite 1801

Houston, Texas, 77030, United States

Location

Related 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.

    PMID: 20925074BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Christine Hunter
Organization
Baylor College of Medicine
chunter@bcm.edu
713-798-6556

Study Officials

  • William G Ondo, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 10, 2008

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

March 14, 2023

Results First Posted

March 14, 2023

Record last verified: 2023-02

Locations

US(1)