Rimonabant for Improving Walking Ability in Patients With Chronic Stroke

The mail goal of this clinical trial is assess the effect of rimonabant in walking ability in people who experienced a stroke at least 12 months before enrollment. It will include 80 adults aged 18 to 75 years that will receive either rimonabant (5 mg) or placebo (a look-alike tablet that contains no drug) once daily for 90 days. Neither the participants nor the investigators will know which treatment is being given. The study will also help to learn about the safety of rimonabant.

Inclusion Criteria: * Age between 18 and 75 years. * More than 12 months since diagnosis of stroke (chronic phase). * Modified Rankin Scale score between 2 and 4. * Ability to walk at least 5 meters with or without assistance. * Capacity to provide written informed consent. * Preserved cognitive functions to adequately comply with study assessments. Exclusion Criteria: * High risk of suicide as assessed by the C-SSRS scale. * History of severe psychiatric disorders, major depression or prior suicide attempts. * Treatment with anticoagulants or strong CYP3A4 inhibitors or inducers (inhibitors such as ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, or nefazodone, and inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, or St. John's Wort). * Body Mass Index (BMI) \> 40 kg/m². * Pregnancy or breastfeeding. * Fertile men or women who cannot guarantee the use of highly effective contraceptive methods, as defined by the European HMA-CTFG guidelines at least 45 days after the last dose of rimonabant -i.e., those with a failure rate of less than 1 % per year when used consistently and correctly (CTFG, 2020). * Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease. * Inability to attend hospital visits. * Known allergy to rimonabant or any of the excipients used. * Participation in another clinical trial within the month prior to enrolment. * Any other condition that, in the opinion of the investigator, makes the subject's participation in the study unrecommended, such as severe heart failure or uncontrolled diabetes. * COPD or other severe chronic respiratory disease, chronic fatigue syndrome, severe congestive heart failure, orthopaedic ambulatory impediments (like severe arthritis) or other comorbidities that, according to the investigator's judgement, may substantially limit walking performance independently of stroke-related impediments. * Impaired walking capabilities with a baseline 6MWT distance ≥400 m.