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Clinical Trial Summary

The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.


Clinical Trial Description

Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.

The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00507715
Study type Interventional
Source Rottapharm Spain
Contact
Status Completed
Phase Phase 1
Start date September 2006
Completion date November 2006

See also
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Completed NCT05575479 - PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables