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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859792
Recruitment Status : Not yet recruiting
First Posted : August 9, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Riluzole Drug: Placebo Biological: Blood Samples Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
placebo capsules 25 or 50 mg

Biological: Blood Samples
v1;v2;v3;v4

Experimental: Experimental 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).

Biological: Blood Samples
v1;v2;v3;v4




Primary Outcome Measures :
  1. the Minimum Effective Dose (MED) of Riluzole [ Time Frame: 2 Months ]
    Blood Sample



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  10. Written informed consent provided by subject

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 < 4
  4. Presence of urinary infection, fever, pressure ulcer or other spasticity-aggravating factors.
  5. Presence of other significant neurological or mental disorder or other illness, which would preclude accurate evaluation,
  6. Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance,
  7. Insufficient fluency in local language to complete neuropsychological, global and spasticity assessments
  8. Active liver disease or clinical jaundice
  9. Active malignancy or history of invasive malignancy within the last five years
  10. 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).
  11. AIDS or AIDS-related complex,
  12. 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.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859792


Contacts
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Contact: OLIVIER BLIN olivier.blin@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Contact: OLIVIER BLIN       olivier.blin@ap-hm.fr   
Principal Investigator: jean-michel VITON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Catherine GEINDRE Assistance Publique Hopitaux De Marseille
Principal Investigator: OLIVIER BLIN Assistance Publique Hopitaux De Marseille
Principal Investigator: JEAN MICHEL VITON Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02859792    
Other Study ID Numbers: 2016-000901-35
2016-02 ( Other Identifier: ap hm )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents