NCT00507715

Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson's Disease, Idiopathic

Interventions

Type	Name	Description
DRUG	Plantago ovata husk	5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
OTHER	hemicellulose crystalline	5g effervescent powder t.id. during 14 days

Timeline

• Start date: 2006-09-01
• Completion: 2006-11-01
• First posted: 2007-07-26
• Last updated: 2007-07-26

Locations

1 site across 1 country: Spain