Stroke
Conditions
Brief summary
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.
Detailed description
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).
Interventions
Sponsors
Sinfatin S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Outcome results
None listed