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GM1 Ganglioside Effects on Parkinson's Disease

NCT00037830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2012-12-21

Study results available
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Summary

The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks) with GM1 on disease progression, and to examine the extent to which GM1 treatment influences the underlying disease process in PD.

Conditions

  • Parkinson Disease

Interventions

DRUG

GM1 ganglioside

100 mg twice per day by subcutaneous injection

DRUG

Placebo

Twice per day subcutaneous injection, equal volume as active drug

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Jay S. Schneider, Ph.D. · Parkinson's Disease Research Unit, Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
39 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00037830 on ClinicalTrials.gov