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

Parkinson's Disease, Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507715
• Other study ID #: PLAN-EC-LDOPA-FI
• Secondary ID: EudraCT number:2
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2007
• Last updated: July 25, 2007
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: July 2007
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease, Idiopathic

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de León	Leon	León

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.		14 days
Secondary	To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.		14 days