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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease, Idiopathic

Intervention / Treatment
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* Drug: Plantago ovata husk
* Other: hemicellulose crystalline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Plantago ovata husk | Drug: Plantago ovata husk<br>* 5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days<br>|
| Placebo Comparator: 2<br>hemicellulose crystalline | Other: hemicellulose crystalline<br>* 5g effervescent powder t.id. during 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc. |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk