Health Condition 1: G802- Spastic hemiplegic cerebral palsy
Conditions
Sponsors
Modi-Mundipharma Pvt Ltd.
CliniExperts Services Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 2 to 17 years with spasticity due to neurological disorders. 2. Minimum weight of 10 kg at the screening and day 1 visits. 3. Ankle spasticity equal to or greater than 2 in affected lower limb, as measured on the Modified - Ashworth Scale and GMFM-66. 4. Equinovarus or equinovalgus deformities are acceptable. 5. No infection or inflammation in the planned injection sites. 6. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period. 7. Subject willing and able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease. 2. Uncontrolled epilepsy as more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit or history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc) more than once a month, seizures lasting more than 10 minutes, status epilepticus, or epilepsy with autonomic involvement. 3. Botulinum Toxin therapy of any serotype for any condition within the last 6 months prior to the day 1 visit. 4. History of surgical intervention of the lower study leg or planned surgery of any limb during the study 5. Previous casting within 6 months prior to the day 1 visit or with a dynamic splint (eg, Dynasplint ) within 3 months prior to the day 1 visit for spasticity of the study limb or affected limb during the study. 6. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. 7. Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates of adverse events (AEs) and serious adverse events (SAEs), Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)Timepoint: Time Frame: week 1, week 4, week 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in the modified- AS score of affected muscle groups 2. GICS Investigator s, patient and parent s/caregiver s will be recorded 3. Spasticity-related pain- as measured by the Questionnaire on pain will be recorded 4. Improvement of motor function (as measured by the Gross Motor Function Measure 66) will be recordedTimepoint: 1. Week 1,4,8 and the final visit (Week 12). 2. Week 1,4, 8 and at the final visit (Week 12). 3. Week 1,4,8 and the final visit (Week 12). 4. Week 1,4,8 and the final visit (Week 12). | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt. Ltd.
Outcome results
None listed