Rimonabant for Improving Walking Ability in Patients With Chronic Stroke

Korábbi kezelés

• 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).
• Participation in another clinical trial within the month prior to enrolment.

Más betegség

• 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.
• Known allergy to rimonabant or any of the excipients used.
• 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.

Egyéb

• High risk of suicide as assessed by the C-SSRS scale.
• Body Mass Index (BMI) > 40 kg/m².
• Pregnancy or breastfeeding.
• Inability to attend hospital visits.
• Impaired walking capabilities with a baseline 6MWT distance ≥400 m.

• 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.