CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
GM1 ganglioside +1 moredrug
Likely dose
GM1 ganglioside 100 mg twice per day by subcutaneous injectionAI-extracted
Key inclusion· 7
  • ✓Age 39–85 years
  • ✓Idiopathic Parkinson's disease diagnosed ≥6 months before screening, with ≥2 cardinal features (tremor, rigidity, bradykinesia, posture/gait disturbance), including rigidity or bradykinesia
  • ✓Modified Hoehn and Yahr stage 1–3 (measured during ≥12 hour off period)
  • ✓UPDRS motor score 10–40 during ≥12 hour off period, and ≥6 during on period
Key exclusion· 23
  • ✕Abrupt onset of parkinsonism
  • ✕Failure of parkinsonian symptoms to respond to levodopa
  • ✕Severe motor complications: peak dose dyskinesias (UPDRS >3), random on–off phenomenon other than end-of-dose wearing-off, or motor fluctuations persisting ≥6 months
  • ✕Tremor UPDRS score >5, or >3 in any individual limb

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00037830
NCT00037830Phase 2Completed
CompareCT.gov

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

Thomas Jefferson University·interventional·Posted May 23, 2002·Updated Dec 21, 2012

In Brief

A Phase 2 clinical trial evaluating GM1 ganglioside and Placebo for Parkinson Disease. Completed, enrolled 94 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2002
Enrollment StartNov 1, 1999
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 24.1 years ago

Interventions

GM1 gangliosidedrug

100 mg twice per day by subcutaneous injection

Placebodrug

Twice per day subcutaneous injection, equal volume as active drug