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

Phase 1

Completed

• Conditions: Parkinson's Disease, Idiopathic
• Interventions: Drug: Plantago ovata husk; Other: hemicellulose crystalline

• Registration Number: NCT00507715
• Lead Sponsor: Rottapharm Spain

Brief 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.

Study Timeline

• Study Start: 2006-09
• Study Completion: 2006-11
• Status Verified: 2007-07
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Last Update Submitted: 2007-07-25
• Study First Posted: 2007-07-26
• Last Update Posted: 2007-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
• At least 3 months of treatment continued of levodopa.
• Patients that give the their consent to participate in the study.

Exclusion Criteria

• Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
• Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Plantago ovata husk	Plantago ovata husk
2	hemicellulose crystalline	hemicellulose crystalline

Primary Outcome Measures

Name	Time	Method
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.	14 days

Secondary Outcome Measures

Name	Time	Method
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.	14 days

Trial Locations

Locations (1)

Hospital de León; 🇪🇸 Leon, León, Spain