drugset / Trial / NCT01102686

Pyrimethamine as a Treatment for Late-Onset GM2-gangliosidosis (Tay-Sachs and Sandhoff Disease)

NCT01102686

Phase 1/2 Completed 20 enrolled The Hospital for Sick Children
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objectives of this clinical trial are to assess the safety and tolerability, as well as efficacy, of a stepwise dosing regimen of pyrimethamine, starting at 25 mg/day, given as a single dose daily for 4 weeks in patients affected with chronic Tay-Sachs or Sandhoff variants.

Timeline

Start
2009-08
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject pyrimethamine Small molecule 100 mg Oral
Background Leucovorin Small molecule 5 mg