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AuthorisedTherapeutic exploratory (Phase II)Interventional

Effects of a CB1 Antagonist/Reverse Agonist (Rimonabant) on Functional Recovery in Stroke Patients During Subacute Phase.

A stroke can cause lasting problems with walking, balance, and everyday activities like washing or dressing. This early-stage study (Phase 2) is testing a medicine called rimonabant to see if it can improve physical recovery in adults who have recently had a stroke. Researchers want to find out whether taking this tablet helps people regain their independence in everyday life. In the study, some participants will receive rimonabant as a tablet that dissolves on the tongue, while others will receive a dummy tablet (placebo) with no active medicine. Doctors will closely check the safety of the treatment. They will track heart health, physical symptoms, and emotional well-being, including mood and anxiety. They will also measure walking speed, arm movement, balance, and tiredness to see whether the medicine makes a meaningful difference to recovery.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Sinfatin S.L.
Enrolment target
80
Start
10 Aug 2026

What is this study about?

When someone has a stroke, blood flow to part of the brain is cut off, which can damage brain cells. This often leads to muscle weakness, stiffness, and trouble carrying out basic daily tasks. The weeks and months shortly after a stroke are a crucial window for healing. Researchers are keen to find new medicines that can work alongside standard rehabilitation to help the brain repair itself.

This clinical trial is testing a drug called rimonabant. It works on certain chemical pathways in the nervous system that may play a role in brain recovery and movement. The main goal is to see if taking this medicine helps patients become more independent—meaning they need less help with things like getting out of bed, eating, and moving around.

Because rimonabant affects the brain, safety is a central focus of this trial. In the past, similar medicines have been linked to changes in mood. For this reason, the research team will keep a close eye on participants' mental health, including screening for symptoms of anxiety or low mood, as well as checking heart rhythms, blood tests, and physical balance.

By comparing patients taking rimonabant with those taking an inactive dummy pill, doctors hope to learn whether this treatment is both safe and effective. If successful, the results could lead to larger studies to help improve stroke care in the future.

Key takeaways

  • Tests whether the medicine rimonabant helps people recover independence after a stroke.
  • Open to adults aged 18 and older in the early recovery phase following a stroke.
  • Uses a dissolving tablet taken by mouth, compared against an inactive dummy pill (placebo).
  • Tracks walking, balance, arm movement, fatigue, and ability to manage daily tasks.
  • Monitors emotional well-being, heart health, and safety very closely throughout.

Who may be eligible?

This study is open to men and women aged 18 and over who have recently had a stroke. It focuses on the 'subacute' phase of recovery, which means the weeks or early months following the stroke when the body and brain are actively trying to regain lost abilities.

To be eligible, you must be in a stable medical condition but still experiencing difficulties with movement or independence. You must also be able to take part in mobility and memory assessments with the research team.

You might not be able to join if you have certain other serious health problems, such as severe heart conditions or specific mental health disorders, or if you are taking medicines that could clash with the study drug. The trial team will review your medical history carefully to make sure taking part is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you aged 18 or older?
  2. Have you had a stroke recently?
  3. Are you currently working to recover your movement and daily independence?
  4. Are you able and willing to attend hospital or clinic appointments for physical assessments?
  5. Are you comfortable completing questions about your mood, memory, and everyday activities?
Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into one of two groups by chance (like flipping a coin). One group will receive rimonabant as an orally disintegrating tablet (a pill that dissolves on your tongue), and the other group will receive an identical dummy tablet (placebo). Neither you nor your doctor will know which one you are taking until the study ends.

You will attend regular clinic visits where doctors and physiotherapists will carry out physical checks. These include timed walking tests, balance checks, and tests of how well your arms and hands move. You will also have routine safety checks, such as blood pressure measurements, blood tests, and heart tracings (ECGs). You will be asked to fill in questionnaires about your mood, energy levels, and swallowing. The study team will explain the exact number of visits and the full schedule before you agree to join.

Potential risks and benefits

Taking part may not help you personally, and you might receive the dummy tablet rather than the active medicine. However, the information gathered may help improve treatments for stroke survivors in the future. As with any medicine, rimonabant carries a risk of side effects, which can include feeling sick, dizziness, or changes in mood such as low feelings or anxiety. You will be monitored closely throughout the study to keep you safe. Joining is completely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain

Common questions

What is rimonabant?

Rimonabant is a medicine that acts on specific receptors in the brain and body. Researchers are studying whether it can help brain cells recover and improve movement after a stroke.

What is a placebo?

A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether any improvements are truly caused by the study drug.

Will taking part replace my normal stroke therapy?

No. The study treatment is designed to be taken alongside standard stroke care and rehabilitation, not to replace your usual physiotherapy or medical treatments.

How will my mood and mental health be checked?

The team will ask you questions about how you are feeling at your appointments and use standard questionnaires to check for any signs of low mood, sadness, or anxiety.

What happens if I decide I want to stop?

You can leave the trial at any point. Your decision will not affect the quality of your usual medical treatment or your relationship with your healthcare team.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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