Spastic Cerebral Palsy
Conditions
Brief summary
Incidence of treatment-emergent adverse events following the first administration of investigational product.
Detailed description
2. Change in the MAS score, PROM, GMFM-66 & GMFCS-E&R., 4. NGF serum concentrations., 1.Incidence of treatment-emergent SAEs, treatment-emergent nonserious AEs, study discontinuation for tolerability reasons. Change on Vital signs, Weight and height, Physical examinations, Clinical laboratory assessments, 12-lead ECG results, EEG results., 3. Change in daily activities & Social/cognitive domains, as assessed by PEDI-CAT, & in communication function as assessed by the CFCS.
Interventions
DRUGThe placebo for investigational lyophilized cenegermin Drug Product is the same as the Drug Product with the exception that it does not contain cenegermin.
DRUGCenegermin
Sponsors
Dompe' Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events following the first administration of investigational product. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Change in the MAS score, PROM, GMFM-66 & GMFCS-E&R., 4. NGF serum concentrations., 1.Incidence of treatment-emergent SAEs, treatment-emergent nonserious AEs, study discontinuation for tolerability reasons. Change on Vital signs, Weight and height, Physical examinations, Clinical laboratory assessments, 12-lead ECG results, EEG results., 3. Change in daily activities & Social/cognitive domains, as assessed by PEDI-CAT, & in communication function as assessed by the CFCS. | — |
Countries
Italy
Outcome results
None listed