Effects of a CB1 Antagonist/Reverse Agonist (Rimonabant) on Functional Recovery in Stroke Patients During Subacute Phase.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 6
- Primary Endpoint
- Safety and tolerability endpoints: • Incidence of treatment adverse events, including AEs/SAEs/AESIs. • Clinically significant changes in physical examination, biochemical parameters, vital signs, and ECG. • Changes in spasticity (MAS), and pain (VAS). • Symptoms of anxiety and depression (BDI-II and HADS). • Number of falls and % of standing activity. • Self-perceived mood.
Study Overview
Brief Summary
To evaluate the effect of rimonabant in improving functional independence in post-stroke patients in subacute phase.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 75 years.
- •Between 14 days and 3 months (14 – 90 days) since the stroke.
- •Modified Rankin Scale (mRS) score between 2 and
- •Barthel Index (BI) score ≤ 70 at screening.
- •Capacity to provide informed consent.
Exclusion Criteria
- •High suicide risk assessed by C-SSRS.
- •Known allergy to Rimonabant or any of the excipients used.
- •Participation in another clinical trial with pharmacological intervention the month prior to enrolment.
- •Any other condition that, in the opinion of the investigator, makes the subject's participation in the study inadvisable, such as severe heart failure or uncontrolled diabetes.
- •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).
- •Patients with a history of ischemic or haemorrhagic stroke resulting in a residual mRS > 1, or with a pre-existing mRS > 1 due to other medical conditions.
- •Body Mass Index > 40 kg/m
- •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—i.e., those with a failure rate of less than 1 % per year when used consistently and correctly
- •Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease.
- •Inability to attend hospital visits.
Arms & Interventions
Rimonabant 5 mg ODT
Intervention: Rimonabant 5 mg ODT (Drug)
Same as the medicine tablets, but without the active ingredient
Intervention: Same as the medicine tablets, but without the active ingredient (Drug)
Outcomes
Primary Outcomes
Safety and tolerability endpoints: • Incidence of treatment adverse events, including AEs/SAEs/AESIs. • Clinically significant changes in physical examination, biochemical parameters, vital signs, and ECG. • Changes in spasticity (MAS), and pain (VAS). • Symptoms of anxiety and depression (BDI-II and HADS). • Number of falls and % of standing activity. • Self-perceived mood.
Safety and tolerability endpoints: • Incidence of treatment adverse events, including AEs/SAEs/AESIs. • Clinically significant changes in physical examination, biochemical parameters, vital signs, and ECG. • Changes in spasticity (MAS), and pain (VAS). • Symptoms of anxiety and depression (BDI-II and HADS). • Number of falls and % of standing activity. • Self-perceived mood.
Efficacy: Primary endpoint: The primary efficacy objective is to assess the effect of rimonabant on the improvement of functional independence, defined as a positive change in the total Barthel Index (BI) score compared with baseline.
Efficacy: Primary endpoint: The primary efficacy objective is to assess the effect of rimonabant on the improvement of functional independence, defined as a positive change in the total Barthel Index (BI) score compared with baseline.
Secondary Outcomes
- Efficacy:Secondary endpoints: • Six-minute walking test (6MWT). • Borg CR10 Scale. • Gait speed via Ten-Meter Walk Test (10MWT). • Timed Up and Go test (TUG). • Fugl-Meyer Assessment for the upper extremities (FMA-UE). • Modified Rankin Scale (mRS).
- • National Institutes of Health Stroke Scale (NIHSS). • Berg Balance Scale (BBS). • Patient Global Impression of Change (PGIC). • Fatigue Severity Scale (FSS). • Multidimensional Fatigue Inventory (MFI-20). • Stroke Impact Scale (SIS 3.0). • EuroQol-5D-5L (EQ-5D-5L). • Swallowing Disturbance Questionnaire (SDQ). • Montreal Cognitive Assessment (MoCA).
Investigators
Eloy Ferreras
Scientific
Sinfatin S.L.