Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study

Condition studied

Complete to incomplete (AIS A-C) sub-acute cervical or thoracic (NLI C4-T10) spinal cord injury (SCI) with severe spastic motor behaviour

Investigational medicinal product(s)

Eligibility

Primary endpoint

Per-patient average of MES scores across the 30 days treatment.

Endpoint detail

Per-patient average of MAS scores across the 30 days treatment, Proportion of days when MES score is 3 or higher., Proportion of days when MAS score is 3 or higher., ADL evaluated by SCI-SET (relevant questions)., Functioning assessed by the Spinal Cord Independence Measure (SCIM-III)., Quality of life evaluated by WHOQOL-BREF questionnaire.