Expired Study
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Milwaukee, Wisconsin


Purpose:

To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.


Study summary:

See approved Package Insert for Adverse Event information.


Criteria:

Inclusion Criteria: - Stable Parkinson's disease Exclusion Criteria: - idiopathic PD with Hoehn and Yahr state II or III


Study is Available At:


Original ID:

SP867


NCT ID:

NCT00139880


Secondary ID:


Study Acronym:


Brief Title:

A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parki


Official Title:

A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

UCB, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:UCB Clinical Trial Call Center
Study Director
UCB, Inc.

Study Dates

Start Date:June 2005
Completion Date:August 2005
Completion Type:Actual
Primary Completion Date:August 2005
Primary Completion Type:Actual
Verification Date:September 2009
Last Changed Date:September 3, 2013
First Received Date:August 29, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Parcopa

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:UCB, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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