Neuroprotective Effects of Glycine for Therapy of Acute Ischemic Stroke

Completed

Phase N/A Results

Trial Description

To assess the safety and the efficacy of glycine in patients with acute ischemic stroke in the carotid artery territory.

Interventions

  • Glycine Drug
    Intervention Desc: NMDA receptor co-agonist, also interacts with glycine receptors and GABA receptors. Believed to correct imbalances between excitatory and inhibitory neurotransmitter systems.

Trial Design

Randomized, double-blind, placebo-controlled trial of 200 patients.

Patient Involvement

Patients were randomized to receive placebo or 1 of 3 doses of glycine (0.5 g/day, 1.06/day, 2.0 g/day). Patients were assessed at the end of treatment (day 6) and at 30 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety, neurological outcome according to Orgogozo Stroke Scale (OSS) and Scandinavian Stroke scale (SSS), functional outcome according to Barthel index, mortality at day 30.
Secondary Enzyme-linked immunosorbent assay (ELISA) of levels of blood serum autoantibodies to NMDA-binding proteins, detection of excitatory (glutamate, aspartate) and inhibitory (glycine, GABA) amino acid concentrations and lipid peroxidation products (TBARS) in CSF.