BridgeMD
RILUSCI
EU CTIS ID: 2024-514882-20-00
What this study is testing
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 versus placebo, in patients with chronic SCI
- Phase I and Phase II (Integrated)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- itten informed consent provided by subject
- Male or Female
- Aged 18 to 65 years at the time of screening
- Judged by site investigator to be able to comply with evaluations at baseline and throughout the study
- 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
You likely can't join if
- Spinal cord injury of less than 12 months,
- Neutropenia, liver enzymes (ALT/SGPT or AST/SGOT) 2 times the upper limit of normal (ULN) at screening visit, baseline elevations of several liver function tests (especially elevated bilirubin).
- AIDS or AIDS-related complex,
- The systolic blood pressure measurement is > 190 or < 85 mm Hg and/or the diastolic blood pressure measurement is > 105 or < 50 mm Hg at screening.
- 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.
- Treatment with any investigational drugs or device within 60 days of screening
See the full eligibility criteria
- 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)
- itten informed consent provided by subject
- Male or Female
- Aged 18 to 65 years at the time of screening
- Judged by site investigator to be able to comply with evaluations at baseline and throughout the study
- 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
- Last intrathecal (IT) injection of baclofen or per os administration of any myorelaxant should be more than 14 days ago (Step 1)
- 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).
- Stable on all other chronic medications for ≥ 30 days prior to screening, including analgesics
- Stable on rehabilitation (methods and frequency) for ≥ 15 days prior to screening
- Spinal cord injury of less than 12 months,
- Neutropenia, liver enzymes (ALT/SGPT or AST/SGOT) 2 times the upper limit of normal (ULN) at screening visit, baseline elevations of several liver function tests (especially elevated bilirubin).
- AIDS or AIDS-related complex,
- The systolic blood pressure measurement is > 190 or < 85 mm Hg and/or the diastolic blood pressure measurement is > 105 or < 50 mm Hg at screening.
- 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.
- Treatment with any investigational drugs or device within 60 days of screening
- Any myorelaxant medication including IT baclofen, taken by the subject in the last 14 days prior to screening (step 1)
- Not stable under IT baclofen or per os myorelaxant medication for at least 30 days prior screening (step 2)
- Not stable on all other chronic medications for ≥ 30 days prior to screening, including analgesics
- injection of BTX-A in striated muscle less than 3 months ago
- 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)
- Associated Brain lesion that might be the cause of spasticity,
- Ongoing pregnancy and women with childbearing potential not using any form of efficacious contraception during study and 3 months after the end of study.
- Ongoing lactation and during 3 months after the end of study.
- known hypersensitivity to Riluzole
- MAS≤1 or =5on at least adductor muscles and/or triceps surae muscles or NRS < 4
- Presence of urinary infection, fever, pressure ulcer or other spasticity-aggravating factors.
- Presence of other significant neurological or mental disorder or other illness, which would preclude accurate evaluation,
- Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance,
- Insufficient fluency in local language to complete neuropsychological, global and spasticity assessments
- Active liver disease or clinical jaundice
- Active malignancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.