Pediatric lower limb (LL) spasticity (SP) caused by cerebral palsy (CP)
Conditions
Brief summary
Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6
Detailed description
Response in derived MAS score of plantar flexors at control visits at week 4 or week 6 with response defined as improvement of at least 1 point on the derived MAS score as compared to study baseline, GICS-PF score at control visits at week 4 and week 6 by investigator, GAS T-score at control visits at week 4 and week 6
Interventions
DRUGXEOMIN 200 V pulveris injekciju šķīduma pagatavošanai
DRUGPlacebo to NT201
DRUGXEOMIN
DRUG200 jednostek
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Response in derived MAS score of plantar flexors at control visits at week 4 or week 6 with response defined as improvement of at least 1 point on the derived MAS score as compared to study baseline, GICS-PF score at control visits at week 4 and week 6 by investigator, GAS T-score at control visits at week 4 and week 6 | — |
Countries
Latvia, Poland
Outcome results
None listed