NCT00037830

GM1 Ganglioside Effects on Parkinson's Disease

The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 39 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed to further examine the extent to which GM1 ganglioside can improve symptoms, delay disease progression, and, perhaps, partially restore damaged brain cells in PD patients. GM1 ganglioside is a chemical that is normally found in the brain and is a normal part of the outer covering or membrane of nerve cells. This study will compare the effectiveness of GM1 to standard PD treatment. In addition to studying clinical measures of motor and cognitive functioning, the investigators will use PET (positron emission tomography) scanning to image the brain and the dopamine nerve endings in a subgroup of patients. Patients with mild to moderate idiopathic PD will be divided into 2 groups. One group will receive GM1 for 24 weeks and the other will receive placebo. At the end of this 24 week period, all patients will enter into a 96 week treatment period in which all patients will receive GM1. In parallel, a group of standard-of-care patients with mild to moderate PD will be monitored over a 1 to 2 year period to assess the natural progression of PD. These patients will receive the same clinical evaluations as the treatment group subjects but they will not receive the experimental medication.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	GM1 ganglioside	100 mg twice per day by subcutaneous injection
DRUG	Placebo	Twice per day subcutaneous injection, equal volume as active drug

Timeline

• Start date: 1999-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2002-05-23
• Last updated: 2012-12-21
• Results posted: 2012-08-09

Locations

1 site across 1 country: United States