the traumatic chronic spinal cord injury condition
Conditions
Interventions
Product Name: RILUZOLE
Product Code: RILUZOLE
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: RILUZOLE
CAS Number: 1744-22-5
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
ASISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chronic traumatic SCI defined as: a.At least a 12-month history of i. C4-T12 traumatic SCI ii. Complete and incomplete ( AIS A,B,C,D) iii. With Spasticity (5>MAS>1 on at least adductor muscles and/or triceps surae muscles and NRS = 4) 2.Male or Female 3.Aged 18 to 65 years at the time of screening 4.Judged by site investigator to be able to comply with evaluations at baseline and throughout the study 5.Last injection of BTX-A in striated muscle more than 3 months ago and patients must have returned to their level of spasticity before BTX-A injection 6.Last intrathecal (IT) injection of baclofen or per os administration of any myorelaxant should be more than 14 days ago (Step 1) 7.The dose of myorelaxant or Baclofen should be stable for = 30 days prior to screening and kept at stable daily dose until the end of the protocol (Step 2). 8.Stable on all other chronic medications for = 30 days prior to screening, including analgesics 9.Stable on rehabilitation (methods and frequency) for = 15 days prior to screening 10Written informed consent provided by subject Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Spinal cord injury of less than 12 months, 2.Associated Brain lesion that might be the cause of spasticity, 3.MAS=1 or =5 on at least adductor muscles and/or triceps surae muscles or NRS 190 or 105 or < 50 mm Hg at screening. 13.The ECG is abnormal at screening and judged to be clinically significant by the site investigator. Particular attention will be given to any sign suggesting conduction disorders. 14.Treatment with any investigational drugs or device within 60 days of screening 15.Any myorelaxant medication including IT baclofen, taken by the subject in the last 14 days prior to screening (step 1) 16.Not stable under IT baclofen or per os myorelaxant medication for at least 30 days prior screening (step 2) 17.Not stable on all other chronic medications for = 30 days prior to screening, including analgesics 18.Injection of BTX-A in striated muscle less than 3 months ago 19.Subject is currently using, and will continue to use for the next 14 days any of the following medications which are classified as Inhibitors of CYP 1A2 (e.g. diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) or Inducers of CYP 1A2 (e.g. rifampicin and omeprazole) 20.Ongoing pregnancy or lactation. Women with childbearing potential not using any form of efficacious contraception. 21.Known hypersensitivity to Riluzole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI;Secondary Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.;Primary end point(s): is defined as the improvement of Modified Ashworth Score better than 1 point, or 11 points Numerical Rating Scale (0-10 NRS) spasticity score better than 20% between Week 0 and Week 2.;Timepoint(s) of evaluation of this end point: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety : side effects Pharmacokinetics (PK) Electrophysiology Efficacy Pain Bladder dysfunctiont ;Timepoint(s) of evaluation of this end point: 5 weeks | — |
Countries
France
Contacts
Public ContactGIULIANI
AP HM
Outcome results
None listed