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

NCT02859792 | Unknown Phase 2 DMC

• 2 other identifiers: 2016-000901-352016-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted in two steps:

1. 1.Determination of the Minimal Effective Dose (MED) among the four doses of the panel
2. 2.Estimation of the probability of response associated to the MED.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• the Minimum Effective Dose (MED) of Riluzole

  Blood Sample

  2 Months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Biological: Blood Samples

Experimental

EXPERIMENTAL

Drug: Riluzole; Biological: Blood Samples

Interventions

Riluzole DRUG

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).

Experimental

Placebo DRUG

placebo capsules 25 or 50 mg

Placebo

Blood Samples BIOLOGICAL

v1;v2;v3;v4

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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
• Written informed consent provided by subject

You may not qualify if:

• Spinal cord injury of less than 12 months,
• Associated Brain lesion that might be the cause of spasticity,
• MAS≤1 or =5 on 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 or history of invasive malignancy within the last five years
• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (1)

• Cotinat M, Boquet I, Ursino M, Brocard C, Jouve E, Alberti C, Bensoussan L, Viton JM, Brocard F, Blin O. Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial. PLoS One. 2023 Jan 20;18(1):e0276892. doi: 10.1371/journal.pone.0276892. eCollection 2023.

  PMID: 36662869 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Riluzole; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Catherine GEINDRE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• OLIVIER BLIN

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

• JEAN MICHEL VITON

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OLIVIER BLIN

CONTACT

olivier.blin@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 9, 2016
• Study Start: May 27, 2019
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)