Rimonabant for Improving Walking Ability in Patients With Chronic Stroke

Endpoints

Primary

Six-Minute Walk Test (6MWT)

Timeframe: Baseline to end of follow-up (day 135)

Secondary (19)

Six-Minute Walk Test (6MWT) -EOT

Borg CR10 Scale

6MWT Clinically Relevant Improvement

Ten-Meter Walk Test (10MWT)

Multidimensional Fatigue Inventory (MFI-20)

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Fatigue Severity Scale (FSS)

Stroke Impact Scale (SIS 3.0)

Five-level EuroQol five-dimension questionnaire (EQ-5D-5L)

Patient Global Impression of Change (PGIC)

Adverse Events (AEs)

Serious Adverse Events (SAEs)

Adverse Events of Special Interest (AESIs)

Beck Depression Inventory-II (BDI-II)

Hospital Anxiety and Depression Scale (HADS)

The Visual Analogue Scale for Pain (VAS-P)

Spasticity Assessed by Modified Ashworth Scale (MAS)

Penn Spasm Frequency Scale (PSFS)

Number of Falls

Daily Standing Activity

Arms and interventions

Rimonabant 5 mgExperimental

Participants randomized to receive rimonabant 5 mg.

PlaceboPlacebo comparator

Participants randomized to receive matching placebo.

Drugs: Rimonabant, Placebo

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