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Rimonabant for Improving Walking Ability in Post‑Stroke Patients in the Chronic Phase

Fast replyInvestigationalNo placebo

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What is this trial about?

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

The trial focuses on adults who have experienced a stroke and are in the chronic phase, meaning the event occurred many months ago and the condition is stable. The investigational medicine is a 5 mg oral dispersible tablet of Rimonabant, a type of drug that blocks the CB1 receptor in the brain, which may influence muscle tone and motivation. A matching placebo tablet that looks the same but contains no active ingredient is also used for comparison.

The aim of the study is to determine whether the drug can improve walking capacity in this population. Participants are randomly assigned to receive either the active tablet or the placebo for a defined period, with regular clinic visits for safety checks, blood pressure and heart rate monitoring, and simple questionnaires about mood and pain. At the start and at the end of the treatment period, each participant performs a six-minute walking test, in which the distance walked in six minutes is recorded.

Safety is assessed by recording any unwanted effects, checking basic blood work, and performing an electrocardiogram (ECG), a quick test that records the heart’s electrical activity. Functional outcomes include the walking distance, speed measured over a short distance, and self‑reported fatigue and quality of life. The study also tracks the number of falls and overall activity level to provide a broader picture of daily function.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
You agree to take part in the study after receiving information about what will be required.
Your written consent is recorded before any study procedures begin.
Step 2
Baseline examinations
A health professional performs a physical examination, takes blood samples, records an electrocardiogram (a test of heart rhythm), and measures temperature, blood pressure, and heart rate.
You complete questionnaires that assess muscle tightness, pain, anxiety, depression, mood, and the number of falls you have experienced.
Your walking ability is measured with a six‑minute walking test, where you walk as far as possible for six minutes.
Step 3
Random assignment to study medication
You are assigned, by chance, to receive either rimonabant 5 mg oral dispersible tablet or a matching tablet that does not contain the active ingredient (placebo).
The assignment is unknown to you and the staff who evaluate the outcomes.
Step 4
Taking the study medication
You take one tablet containing 5 mg of rimonabant or the identical placebo tablet according to the schedule given by the study staff.
The medication is taken by mouth and allowed to dissolve in the mouth before swallowing.
You continue to take the tablet for the entire period of the study, following any instructions about timing and whether to take it with food.
Step 5
Regular safety and health checks
At scheduled visits you undergo repeat physical examinations, blood tests, electrocardiograms, and vital‑sign measurements.
The staff asks about any new symptoms, side effects, or health problems you may have experienced since the last visit.
Step 6
Repeated walking and function assessments
Periodically you repeat the six‑minute walking test to see how far you can walk.
You also complete the Borg CR10 Scale, which asks you to rate how hard you felt you were working after the walk.
Your walking speed is measured with a ten‑meter walk test, and you answer additional questionnaires about fatigue, overall stroke impact, and quality of life.
Step 7
Final study visit
At the end of the study you undergo a final set of examinations that include the same physical checks, laboratory tests, and questionnaires as at the start.
The six‑minute walking test and all other functional assessments are repeated one last time.
The study medication is stopped after this visit.

Who can join the trial?

6 criteria

Age: You must be between 18 and 75 years old.
Time since stroke: It must have been more than 12 months since you had a stroke, which means you are in the chronic phase (the long‑term recovery period).
Modified Rankin Scale score between 2 and 4: This scale measures disability after a stroke; a score of 2‑4 indicates moderate disability but the ability to walk with help or independently.
Walking ability: You need to be able to walk at least 5 meters (about the length of a short hallway), with or without someone assisting you.
Written informed consent: You must be able to read, understand, and sign a document that explains the study so you agree to take part.
Cognitive functions: Your thinking, memory, and understanding must be good enough to follow the study instructions and complete the required tests.

Who cannot join the trial?

11 criteria

Having a high risk of suicide, as measured by a questionnaire called the C‑SSRS (Columbia‑Suicide Severity Rating Scale).
Having a past or current severe mental illness such as major depression, other serious psychiatric disorders, or previous suicide attempts.
Currently taking blood‑thinning medicines (anticoagulants) or medicines that strongly affect how drugs are broken down in the body, known as CYP3A4 inhibitors or inducers (examples include ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, carbamazepine, and St. John’s Wort).
Having a body weight that results in a Body Mass Index (BMI) greater than 40 kg/m². BMI is a simple calculation that compares weight to height.
Being pregnant or breastfeeding.
Being able to become pregnant (for women) or able to father a child (for men) and not being able to use a very reliable birth‑control method (methods that prevent pregnancy more than 99 % of the time when used correctly, such as hormonal pills, hormonal implants, intrauterine devices, tubal sterilization, a partner’s vasectomy, or complete sexual abstinence).
Having an underactive thyroid that is not controlled (called uncontrolled hypothyroidism) or having serious problems with the bones, liver, or kidneys.
Being unable to go to the required hospital visits for the study.
Having a known allergy to the study drug rimonabant or any of its inactive ingredients.
Having taken part in another clinical trial within the month before joining this study.
Having any other health condition that the doctor thinks makes participation unsafe, such as severe heart failure or diabetes that is not well‑controlled.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacio Institut Guttmann
Badalona, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain

Trial locations

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Investigated drugs

Rimonabant is an oral tablet that dissolves in the mouth. It works by blocking a specific receptor in the brain called the CB1 receptor. In this study, the medicine is being tested to see if it can help people who have had a stroke improve their ability to walk. Participants take the tablet regularly while the researchers measure how far they can walk in six minutes, which helps determine if the drug can boost walking capacity during the chronic phase after a stroke.

What is already known about the treatment

Rimonabant 5 mg ODT
This medication is taken by mouth as a dispersible tablet that dissolves on the tongue. It was once approved for weight loss but was withdrawn from the market because of mood‑related side effects, although it is still studied in research. Rimonabant is mainly used to block the CB1 cannabinoid receptor, which reduces appetite and may influence brain pathways that help with movement after a stroke. It belongs to the class of cannabinoid receptor antagonists (anti‑obesity agents).
Placebo
The placebo looks like the Rimonabant tablet but contains no active drug and is taken by mouth in the same way. It is used in the trial as a control to show what happens without the effect of the active medication. The tablet has no therapeutic purpose and serves only to compare results. It is not classified as a medication.

Investigated diseases

Stroke - Stroke is a sudden loss of brain function caused by an interruption of blood flow or bleeding in the brain. It can affect movement, speech, and thinking. In the acute phase symptoms appear quickly, then over weeks to months the brain may recover some abilities while deficits may persist. Over time some people experience muscle stiffness, weakness, or difficulty walking. The condition can evolve into a chronic phase where functional limitations become stable but may slowly improve with rehabilitation.