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Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition

NCT02859792 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-04-21

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Riluzole

Riluzole capsules (25 or 50 mg) will be administered in the four dose level groups (i.e. 25 mg bid; 50 mg bid; 75 mg bid; 100 mg bid).

DRUG

Placebo

placebo capsules 25 or 50 mg

BIOLOGICAL

Blood Samples

v1;v2;v3;v4

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Catherine GEINDRE · Assistance Publique Hopitaux De Marseille

  • OLIVIER BLIN · Assistance Publique Hopitaux De Marseille

  • JEAN MICHEL VITON · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859792 on ClinicalTrials.gov