Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk - Full Text View

Sponsored by:	Madaus, S.A.
Information provided by:	Madaus, S.A.
ClinicalTrials.gov Identifier:	NCT00507715

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease, Idiopathic	Drug: Plantago ovata husk Other: hemicellulose crystalline	Phase I

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Hemicellulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

Further study details as provided by Madaus, S.A.:

Primary Outcome Measures:

To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa. [ Time Frame: 14 days ]

Secondary Outcome Measures:

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

Enrollment:	18
Study Start Date:	September 2006
Study Completion Date:	November 2006

Arms	Assigned Interventions
1: Experimental Plantago ovata husk	Drug: Plantago ovata husk 5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
2: Placebo Comparator hemicellulose crystalline	Other: hemicellulose crystalline 5g effervescent powder t.id. during 14 days

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.

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507715

Locations

Spain, León
Hospital de León
Leon, León, Spain, 24071

Sponsors and Collaborators

Madaus, S.A.

Investigators

Study Chair:	Sierra Matilde, Ph, phD	Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)
Principal Investigator:	Carriedo Demetrio, MD	Hospital de León, León (Spain)

More Information

Study ID Numbers:	PLAN-EC-LDOPA-FI, EudraCT number:2006-000491-33
Study First Received:	July 25, 2007
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00507715
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Madaus, S.A.:

Parkinson's Disease, Idiopathic
l-dopa levels
plantago ovata husk

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Dihydroxyphenylalanine
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009