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CTRI Number  CTRI/2026/01/100191 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   This study is being done in India to check if the medicine Xeomin is safe and works well for treating lower limb stiffness in children and teenagers. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CE-CT-XMLL-02-2024 Version 1.0 Dated 15-May-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vishal Vishnoi 
Designation  Associate Professor 
Affiliation  Subharti Medical College And Hospital 
Address  Subharti Medical College And Hospital, Ground Floor Pediatrics Department, Subharti Puram NH-58, Delhi-Haridwar Bypass Road, Meerut, 25005,UP, India

Meerut
UTTAR PRADESH
250005
India 
Phone  9643707691  
Fax    
Email  dr.vishal.vishnoi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena RM 
Designation  Head - Medical Affairs 
Affiliation  CliniExperts Research Services Pvt. Ltd. 
Address  RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India Bangalore KARNATAKA 560064 India

Bangalore
KARNATAKA
560064
India 
Phone  9880902005  
Fax    
Email  veena.rm@cliniexpertsresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Kumar 
Designation  CEO  
Affiliation  CliniExperts Research Services Pvt Ltd 
Address  Unit No. 325, City Centre all, Plot No. 5, Sector 12, Dwarka, New Delhi, South West, DELHI - 110075

South West
DELHI
110075
India 
Phone  9999219448  
Fax    
Email  ashwini.kumar@cliniexpertsresearch.com  
 
Source of Monetary or Material Support  
Modi-Mundipharma Pvt Ltd. 1400, Modi Tower,98 Nehru Place,New Delhi-110019. 
 
Primary Sponsor  
Name  Modi-Mundipharma Pvt Ltd. 
Address  1400, Modi Tower,98 Nehru Place, New Delhi-110019. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
CliniExperts Services Private Limited  D-701, New Rajput CGHS Ltd., Plot No-23, Sector-12, Dwarka New Delhi(India)110078 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prateek Kumar Panda  AIIMS, Rishikesh  Pediatric Neurology Division, Department of Pediatrics, 6th Floor, AIIMS, Rishikesh, District-Dehradun, Uttarakhand
Dehradun
UTTARANCHAL 		 9650149735

prateek.pedia@aiimsrishikesh.edu.in  
Dr Sandeep Bhagwan Patil  Epicare Clinic  Office No. 701,7th Floor, 7 Business Square, Ganeshkhind Rd, behind Datta Mandir, Model Colony, Shivajinagar, Pune, Maharshtra-411016, India
Pune
MAHARASHTRA 		 9673901863

drsandeep.patil@gmail.com 
Dr Pradeep Nanjappa  Mysore Medical College & Research Institute  Room no. 440 ,First Floor, Department of Pediatrics Department of Pediatrics Cheluvamba Hospital, Opposite to MMC&RI, Irwin Road, Mysore-570001
Mysore
KARNATAKA 		 9611898080

drpradeepn80@yahoo.com 
Dr Vishal Vishnoi  Subharti Medical College And Hospital  OPD No.2, Ground Floor, Department of Pediatrics, Subharti Medical College And Hospital, Subharti Puram NH-58, Delhi- Haridwar Bypass Road, Meerut, 250005,UP India
Meerut
UTTAR PRADESH 		 9643707691

dr.vishal.vishnoi@gmail.com 
Dr Chamanpreet singh gandhi  Tulsi Hospital India Limited  1st floor,room no.325 Department of Pediatrics, Tulsi Hospital India Limited, 14/116-A, Civil Lines, Kanpur-208001, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9415134349

cgknpur@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
AIIMS, Rishikesh Institutional Ethics Committee  Approved 
Mysore Medical College and Associate Hospital  Submittted/Under Review 
Subharti Medical College and Hospital  Approved 
Supreme Independent Ethics Committee  Submittted/Under Review 
Tulsi Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  XEOMIN 50 units powder for solution for injection XEOMIN 100 units powder for solution for injection  Pharmaceutical Form - Powder for solution for injection. One vial contains 50 or 100 units of Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, 1 mg human albumin, 4.7 mg sucrose. Dose: 2 U/kg BW per limb (max 50 U per limb, 100 U bilateral), with muscle-specific ranges as per protocol. Route: Intramuscular. Frequency & Duration: Single administration (one treatment cycle only) and Follow-up assessments for 12 weeks post-injection.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence rates of adverse events (AEs) and serious adverse events (SAEs),
Treatment – emergent adverse events (TEAEs) and serious adverse events (SAEs)  		 Time Frame: week 1, week 4, week 8, week 12
 
 
Secondary Outcome  
Outcome  TimePoints 
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 recorded 		 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). 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   19/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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