NCT00004733

Brief Summary

The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2000

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 2004

First QC Date

February 25, 2000

Last Update Submit

June 23, 2005

Conditions

Parkinson's Disease

Keywords

Parkinson'sELLDOPAL-dopalevodopaSinemettremor

Interventions

levodopaDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early, mild PD, not requiring medications
  • Age 30 or older
  • Duration from time of diagnosis of PD: less than 2 years
  • Hoehn \& Yahr Stage 1 or 2
  • Exposure to levodopa or dopamine agonist of 14 days or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Health Sciences

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseTremor

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Stanley Fahn

    Columbia University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 25, 2000

First Posted

February 28, 2000

Study Start

January 1, 1998

Study Completion

February 1, 2004

Last Updated

June 24, 2005

Record last verified: 2004-02

Locations

US(1)