Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition
Status:
Unknown status
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
The study will be conducted in two steps:
1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel
2. Estimation of the probability of response associated to the MED.
Each step has a main objective:
Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients
with chronic SCI
Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve
spasticity vs placebo, in patients with chronic SCI.