Table 1

Schedule of assessments and procedures

Study PeriodScreening and randomizationPeriod IWash-outPeriod II
Visit1 (T0)2 (T1)34 (T2)
Informed consentX
DemographyX
Medical and treatment historyX
Physical and neurological examinationXXXX
Full cardio evaluationX
Cardio consultation ‘as needed’XXX
Vital signsXXXX
Inclusion and exclusion criteriaX
Modified Ashworth scaleXXX
Spasticity NRSXXX
Stretch reflex evaluationXXX
Check patients diaryXX
Spasticity NRS, Pain NRS, Bladder dysfunction NRS X X
Spasms number X X
Sleep quality NRS X X
Blood pressure and heart rate X X
Dispense study drugXX
Check of returned study drugXX
Adverse eventsXXX
Concomitant medicationsXXXX
  • NRS, numerical rating scale.