NCT00507715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
Last Updated

July 26, 2007

Status Verified

July 1, 2007

First QC Date

July 25, 2007

Last Update Submit

July 25, 2007

Conditions

Parkinson's Disease, Idiopathic

Keywords

Parkinson's Disease, Idiopathicl-dopa levelsplantago ovata husk

Outcome Measures

Primary Outcomes (1)

  • To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.

    14 days

Secondary Outcomes (1)

  • To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.

    14 days

Study Arms (2)

1

EXPERIMENTAL

Plantago ovata husk

Drug: Plantago ovata husk

2

PLACEBO COMPARATOR

hemicellulose crystalline

Other: hemicellulose crystalline

Interventions

Plantago ovata huskDRUG

5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days

1
hemicellulose crystallineOTHER

5g effervescent powder t.id. during 14 days

2

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de León

León, León, 24071, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sierra Matilde, Ph, phD

    Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)

    STUDY CHAIR

  • Carriedo Demetrio, MD

    Hospital de León, León (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

September 1, 2006

Study Completion

November 1, 2006

Last Updated

July 26, 2007

Record last verified: 2007-07

Locations

ES(1)