Fig 1.
Standard protocol items recommended for interventional trials (SPIRIT).
Schedule of enrolment, intervention and assessments. The study schedule will be the same in step 1 and in step 2 and it includes the following visits and clinical examinations. Patients with chronic SCI will undergo a screening period (v1) with a maximum duration of 2 weeks and then they will be randomized to one of the two groups (v2): riluzole twice daily or placebo twice daily for a 2 weeks period. Three follow up visits are planned: at day3 after the beginning of treatment for PK analysis (v3), and at the end of the 2 weeks treatment period (v4) and one week after withdrawal of study medication (v5).
Fig 2.
CONSORT diagram.