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| Sponsored by: |
UCB |
|---|---|
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00139880 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Parcopa |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Double-Blind, Dose Comparison, Crossover Assignment |
| 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 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | SP867 |
| Study First Received: | August 29, 2005 |
| Last Updated: | April 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00139880 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Ganglion Cysts Movement Disorders Parkinson Disease Sinemet Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
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Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |