Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT02859792
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2016-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RILUSCI
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-02 | OTHER | ap hm | View |