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Effect of Rimonabant on Functional Recovery in Subacute Stroke Patients

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What is this trial about?

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

The study focuses on patients who have experienced a Stroke and are in the subacute phase, which means the period of recovery that follows the initial emergency but before long‑term rehabilitation is complete. The medication being tested is a 5 mg oral dispersible tablet of Rimonabant, a drug that blocks a specific receptor in the brain involved in appetite and metabolism. Participants will be randomly assigned to receive either the active tablet or an identical tablet that does not contain the drug (a placebo), and they will take the assigned tablet for a defined period while attending regular clinic visits.

The purpose of the study is to evaluate whether Rimonabant can improve functional independence, meaning the ability to perform everyday activities without assistance. Throughout the trial, researchers will monitor safety by checking for any side effects, changes in vital signs, and overall well‑being. Functional ability will be assessed using simple tools such as the Barthel Index, which measures how well a person can manage basic tasks like dressing, eating, and moving around, as well as other straightforward tests of walking and balance. The study does not involve any experimental procedures beyond taking the study tablets and attending the scheduled check‑ups.

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
Initial study visit and consent
You will meet with the study staff to confirm that you meet the eligibility criteria for a stroke study in the subacute phase.
The purpose of the study, the procedures, and any potential risks will be explained in plain language.
You will be asked to sign a consent form indicating that you understand the study and agree to take part.
Step 2
Baseline assessments
A series of measurements will be taken to establish your starting condition.
These include a physical examination, vital signs (blood pressure, heart rate), a basic blood test, an electrocardiogram (ecg) to check heart rhythm, and questionnaires that evaluate spasticity, pain, mood, anxiety, and depression.
Functional ability will be measured using the barthel index, a score that reflects how independently you can perform daily activities.
Step 3
Randomization to study medication
Based on a computer‑generated list, you will be assigned to receive either the active drug or a matching placebo.
The active drug is rimonabant 5‑mg oral dispersible tablet, which contains the ingredient rimonabant.
The placebo looks identical but does not contain any active ingredient.
Step 4
Medication instruction and start of treatment
You will be given a supply of the tablets and written instructions on how to take them.
The tablet is taken by mouth, allowed to dissolve in the mouth, and the usual instruction is to take one tablet each day, unless the study protocol specifies a different schedule.
You will be asked to keep a simple diary noting each dose you take and any symptoms you notice.
Step 5
Daily medication administration
Each day you will take the tablet as directed, preferably at the same time each day.
If you miss a dose, you should follow the guidance provided in the instruction sheet rather than taking extra tablets.
Step 6
Regular follow‑up visits
At scheduled intervals throughout the study, you will return to the clinic for follow‑up visits.
During each visit the study staff will check for adverse events (any new or worsening symptoms), repeat vital signs, and may repeat selected laboratory tests.
Functional assessments will be repeated, including the six‑minute walking test, the ten‑meter walk test, the timed up and go test, balance scales, and questionnaires that measure mood, fatigue, and quality of life.
The information collected helps determine whether the medication is safe and whether it improves functional independence.
Step 7
Final assessment and study completion
At the end of the treatment period you will undergo a final set of assessments similar to the baseline visit.
The final barthel index score will be compared with the baseline score to evaluate any change in functional independence.
All study medication will be returned, and you will receive a summary of the study procedures you completed.
You will be thanked for your participation, and any remaining questions can be addressed by the study staff.

Who can join the trial?

6 criteria

Age: you must be between 18 and 75 years old.
You must be between 14 days and 3 months (14–90 days) after having a stroke.
Your score on the Modified Rankin Scale (mRS) must be between 2 and 4. This scale measures how much disability you have after a stroke, with higher numbers indicating more difficulty.
Your score on the Barthel Index (BI) must be 70 or lower when screened. This index rates how well you can do daily activities such as eating, bathing, and walking; lower scores mean you need more help.
You must be able to give informed consent, meaning you understand the study and agree to take part.
Both men and women are allowed to join the study.

Who cannot join the trial?

12 criteria

High suicide risk assessed by the C-SSRS (a questionnaire that measures thoughts or actions related to suicide).
Known allergy to the study drug Rimonabant or to any of the inactive ingredients (called excipients) that are mixed with the drug.
Having taken part in another clinical trial that used a medication within the month before joining this study.
Any other health problem that the doctor believes makes participation unsafe, such as severe heart failure (the heart cannot pump blood well) or uncontrolled diabetes (blood sugar that is not kept under control).
History of severe psychiatric disorders, major depression, or previous attempts to harm oneself.
Currently taking blood‑thinning medicines (anticoagulants) or strong drugs that change how the body processes other medicines (CYP3A4 inhibitors or CYP3A4 inducers), such as ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, carbamazepine, or St. John’s Wort.
Having had an ischemic stroke (a stroke caused by a blocked blood vessel) or a haemorrhagic stroke (a stroke caused by bleeding) that still leaves a disability score higher than 1 on the modified Rankin Scale (mRS), or any other condition that already gives an mRS score higher than 1.
Having a Body Mass Index (BMI) greater than 40 kg/m², which indicates severe obesity.
Being pregnant or breastfeeding.
Being able to become pregnant (fertile men or women) but unable to use a highly reliable form of birth control that has less than 1 % failure per year when used correctly.
Having uncontrolled hypothyroidism (underactive thyroid that is not treated) or a history of serious bone, liver, or kidney disease.
Being unable to come to the required hospital visits for the study.

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Verified sites

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

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

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Investigated drugs

Rimonabant is a medication that blocks the CB1 receptors in the body, which are part of the system that helps control appetite and metabolism. In this study, researchers are testing whether taking rimonabant can help people who have recently had a stroke improve their ability to perform daily activities and become more independent. The drug is given as a small, quickly dissolving tablet that is taken by mouth. Participants receive rimonabant in addition to the usual care they get after a stroke, and the study will compare their recovery to that of patients who receive a placebo.

What is already known about the treatment

Same as the medicine tablets, but without the active ingredient
This product looks like a regular tablet and is taken by mouth, but it contains no active drug. It is used only as a control to compare the effects of the real medication in the study. Because it has no therapeutic ingredient, it is not considered a medicine and has no medical use. It is classified simply as an inert placebo.
Rimonabant 5 mg ODT
This is a dispersible tablet that is taken orally, usually dissolved in the mouth before swallowing. Rimonabant was previously approved as a weight‑loss drug but was withdrawn in many regions because of safety concerns, and it is now mainly studied in research. It is being tested to help stroke patients regain function by blocking the CB1 receptor, which changes how certain brain signals work. It belongs to the class of CB1 antagonists or reverse agonists.

Investigated diseases

Stroke - Stroke is a sudden loss of brain function caused by interruption of the blood supply to part of the brain. It may result from a blocked vessel (ischemic) or from bleeding into the brain tissue (hemorrhagic). The lack of oxygen makes brain cells in the affected area die. Symptoms start abruptly and can include weakness, trouble speaking, and changes in vision. During the first days, swelling and additional damage can spread to nearby tissue. Recovery follows a variable course as the brain gradually reorganizes over weeks to months.