CTRI/2026/01/100191RecruitingUnknown
A Phase IV, Prospective, Open Label, Multi-Centre, Single arm, Post market surveillance study to confirm the safety and efficacy of Intramuscular Injection of Xeomin (Clostridium Botulinum neurotoxin type A) in the Management of Lower Limb Spasticity in the Indian Pediatric and Adolescent population.
Modi-Mundipharma Pvt Ltd.5 sites in 1 country48 target enrollmentStarted: January 19, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 5
- Primary Endpoint
- Incidence rates of adverse events (AEs) and serious adverse events (SAEs),
Study Overview
Brief Summary
This study aims to evaluate the safety and efficacy of Clostridium Botulinum neurotoxin type A, Xeomin, for the management of lower limb spasticity in the Indian pediatric and adolescent population. The primary objective is to assess safety by monitoring the incidence of adverse events, serious adverse events, and treatment-emergent adverse events from baseline to follow-up. The secondary objective is to evaluate efficacy through changes in modified Ashworth Scale scores, Global Impression of Change Scores by investigators, patients, and caregivers, spasticity-related pain using a questionnaire, and improvement in motor function using the Gross Motor Function Measure-66. These parameters will be assessed at baseline, Week 4, Week 8, and Week 12.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2.00 Year(s) to 17.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 2 to 17 years with spasticity due to neurological disorders.
- •Minimum weight of 10 kg at the screening and day 1 visits.
- •Ankle spasticity equal to or greater than 2 in affected lower limb, as measured on the Modified.
- •Ashworth Scale and GMFM-
- •Equinovarus or equinovalgus deformities are acceptable.
- •No infection or inflammation in the planned injection sites.
- •Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- •Subject willing and able to comply with the study protocol.
Exclusion Criteria
- •Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease.
- •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.
- •Botulinum Toxin therapy of any serotype for any condition within the last 6 months prior to the day 1 visit.
- •History of surgical intervention of the lower study leg or planned surgery of any limb during the study
- •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.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •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.
Outcomes
Primary Outcomes
Incidence rates of adverse events (AEs) and serious adverse events (SAEs),
Time Frame: Time Frame: week 1, week 4, week 8, week 12
Treatment – emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: Time Frame: week 1, week 4, week 8, week 12
Secondary Outcomes
- 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)
Investigators
Dr Vishal Vishnoi
Subharti Medical College And Hospital
Study Sites (5)
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