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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-02 | Other Identifier | ap hm |
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The study will be conducted in two steps:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Minimum Effective Dose (MED) of Riluzole | Blood Sample | 2 Months |
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Inclusion 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)
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| OLIVIER BLIN | Contact | olivier.blin@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Catherine GEINDRE | Assistance Publique Hopitaux De Marseille | Study Director |
| OLIVIER BLIN | Assistance Publique Hopitaux De Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36662869 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019782 | Riluzole |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
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| Placebo | Drug | placebo capsules 25 or 50 mg |
|
| Blood Samples | Biological | v1;v2;v3;v4 |
|
| JEAN MICHEL VITON |
| Assistance Publique Hopitaux De Marseille |
| Principal Investigator |
| D014947 | Wounds and Injuries |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |