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

Rottapharm

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease, Idiopathic

Treatments

Other: hemicellulose crystalline

Drug: Plantago ovata husk

Study type

Interventional

Funder types

Industry

Identifiers

NCT00507715

PLAN-EC-LDOPA-FI

EudraCT number:2006-000491-33

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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.