Trials / Unknown
UnknownNCT02859792
Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
| DRUG | Placebo | placebo capsules 25 or 50 mg |
| BIOLOGICAL | Blood Samples | v1;v2;v3;v4 |
Timeline
- Start date
- 2019-05-27
- Primary completion
- 2023-11-01
- Completion
- 2023-12-01
- First posted
- 2016-08-09
- Last updated
- 2023-04-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02859792. Inclusion in this directory is not an endorsement.