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Study on Riluzole for Reducing Spasticity in Patients with Chronic Spinal Cord Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Riluzole on a condition known as spasticity, which often occurs in individuals with a chronic spinal cord injury. Spasticity is a condition where muscles become stiff or tight, making it difficult to move. The study aims to find out if Riluzole can help improve this condition. Participants in the trial will receive either Riluzole in capsule form or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine the most effective dose of Riluzole for reducing spasticity and to compare its effectiveness against a placebo. The study will be conducted in two steps. In the first step, researchers will identify the minimal effective dose of Riluzole that helps improve spasticity. In the second step, they will assess how well this dose works compared to the placebo. Participants will take the medication orally, and the study will monitor changes in their condition over time.

Throughout the study, participants will be evaluated for any side effects and changes in their spasticity levels. The study will also look at other factors such as pain levels, muscle function, and overall quality of life. The trial is designed to be adaptive, meaning it can adjust based on the results observed during the study. This approach helps ensure that the most effective treatment options are identified for individuals with chronic spinal cord injury and spasticity.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide written informed consent to participate.
Eligibility criteria include having a chronic spinal cord injury with spasticity, being between 18 and 65 years old, and having stable medication and rehabilitation routines.
Step 2
Step 1: dose determination
The first step involves determining the Minimal Effective Dose (MED) of Riluzole that improves spasticity. The patient will receive one of the following: a placebo capsule, a 25 mg Riluzole capsule, or a 50 mg Riluzole capsule, all taken orally.
The goal is to find the dose that shows improvement in spasticity, measured by the Modified Ashworth Score and Numerical Rating Scale over a two-week period.
Step 3
Step 2: efficacy evaluation
In the second step, the efficacy of the determined Minimal Effective Dose of Riluzole will be evaluated against a placebo. This phase is a double-blind trial, meaning neither the patient nor the researchers know who receives the active medication or placebo.
The patient will continue to take the assigned capsule daily, and various assessments will be conducted, including spasticity scores, safety evaluations, and pharmacokinetic studies.
Step 4
Assessments and evaluations
Throughout the trial, the patient will undergo regular assessments to monitor spasticity, pain, and overall health. These include the Modified Ashworth Score, Numerical Rating Scale, and other scales for pain and spasm frequency.
Additional evaluations may include blood sampling for pharmacokinetic analysis and electrophysiological tests to measure nerve and muscle activity.
Step 5
Completion of the trial
The trial is expected to conclude by May 2025. Upon completion, the patient's data will be analyzed to determine the effectiveness and safety of Riluzole in treating spasticity in chronic spinal cord injury.
The results will contribute to understanding the potential benefits of Riluzole for this condition.

Who can join the trial?

11 criteria

Have a **chronic traumatic spinal cord injury (SCI)**, which means an injury to the spine that happened at least 12 months ago.
Experience **spasticity**, which is a condition where muscles are continuously contracted, causing stiffness or tightness.
Be able to provide **written informed consent**, which means you agree to participate in the study after understanding all the details.
Be either male or female.
Be between the ages of 18 and 65 at the time of screening.
Be judged by the study investigator as able to follow the study procedures and evaluations.
Have had the last injection of **Botulinum Toxin A (BTX-A)** in muscle more than 3 months ago and returned to the previous level of spasticity before the injection.
Have had the last injection of **baclofen** into the spinal fluid or taken any muscle relaxant by mouth more than 14 days ago for Step 1 of the study.
Have a stable dose of muscle relaxant or baclofen for at least 30 days before screening and keep it stable until the end of Step 2 of the study.
Be stable on all other long-term medications, including pain relievers, for at least 30 days before screening.
Be stable on rehabilitation methods and frequency for at least 15 days before screening.

Who cannot join the trial?

4 criteria

Patients who are not experiencing spasticity. Spasticity is a condition where muscles are continuously contracted, causing stiffness or tightness.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who do not have a chronic SCI. SCI stands for spinal cord injury, which is damage to the spinal cord that can cause changes in its function.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

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Verified sites

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Assistance Publique Hopitaux De Marseille
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Marseille, France
CENTRE DE REEDUCATION VALMANTE
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Marseille, France

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Investigated drugs

Riluzole is being studied for its potential to improve spasticity in patients with chronic spinal cord injury. The trial aims to find the minimal effective dose that can help reduce muscle stiffness and spasms associated with this condition. The study will also evaluate how effective this medication is in improving spasticity compared to a placebo.

What is already known about the treatment

Riluzole – Riluzole is administered orally in tablet form. It is currently being studied in clinical trials for its potential to treat spasticity in individuals with chronic spinal cord injury. The main therapeutic indication being explored is its ability to reduce muscle stiffness and spasms associated with this condition. At the molecular level, Riluzole works by modulating glutamate neurotransmission, which is believed to help in reducing nerve signal overactivity that leads to spasticity. It is classified pharmacologically as a glutamate release inhibitor.

Investigated diseases

Spasticity – Spasticity is a condition characterized by an abnormal increase in muscle tone or stiffness, which can interfere with movement, speech, or be associated with discomfort or pain. It often occurs in individuals with neurological conditions such as spinal cord injury, multiple sclerosis, or cerebral palsy. The condition results from an imbalance in the signals from the central nervous system to the muscles, leading to involuntary muscle contractions. Over time, spasticity can lead to muscle shortening and joint deformities if not managed properly. It can vary in severity and may affect different parts of the body, depending on the underlying cause. The progression of spasticity can be influenced by factors such as stress, temperature changes, or infections.