Tritherapy (Spinalon)-Elicited Spinal Locomotor Network Activation: Phase 1-2a Clinical Trial in Spinal Cord-Injured Patients
Abstract
. This study aims to assess safety and preliminary efficacy of a first-in-class drug treatment called SPINALON that is designed to acutely trigger episodes of automatic walking in chronic spinal cord-injured patients. It is a single administration, dose escalation, randomized, controlled, and double-blind study which main objective is to determine safety, tolerability and maximum tolerated dose of SPINALON. As a secondary objective, evidence of efficacy (Central Pattern Generator activation and corresponding rhythmic and locomotor-like movement induction) will be sought. The clinical utility of this treatment is to allow correspondingly elicited-regular treadmill training (e.g., active physical activity induced three times per a week) to become a holistic solution for the prevention, reversal or reduction of metabolic and systemic health problems and deregulation (skeletal muscle and bone, cardiovascular, hormonal, immune, neuronal systems) typically found in chronic spinal cordinjured patients.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2012
- Accession Number
- ADA570361
Entities
People
- Pierre A. Guertin