| CTRI Number |
CTRI/2025/10/096066 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| 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 see if a medicine called Xeomin is safe and works well for treating drooling in adults who have nerve or brain-related conditions. |
|
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 Intraglandular Injection of Xeomin (Clostridium Botulinum neurotoxin type A) in the Management of Sialorrhea in Various Neurological Conditions in the Indian adult population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CE-CT-XMSIA-01-2024, Version 1.0 Dated 03-May-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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
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
New Delhi
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 Research Services Pvt Ltd |
Unit No. 325, City Centre all, Plot No. 5, Sector 12, Dwarka, New Delhi, South West, DELHI - 110075 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhukar Shrimantrao Dhondji |
Gajanan Hospital & Critical Care Centre |
Near Gajanan Maharaj Temple Chowk, Opposite Axis Bank, Beside LIC office, Garkheda Road, Aurangabad 431005
Aurangabad
MAHARASHTRA |
9052896555
mady_18@rediffmail.com |
| Dr Prabhat Singh |
MLN Medical College |
George Town, Prayagraj, Uttar Pradesh 211002
Allahabad
UTTAR PRADESH |
9450905978
drprabhat.pgi@gmail.com |
| Dr Surjyaprakash S Choudhury |
Sparsh Hospital And Critical Care Pvt Ltd |
A/407, Sahid Nagar, Bhubaneshwar, Odhisa
Khordha
ORISSA |
9556062436
drsurjyaprakash@gmail.com |
| Dr Vishal Vishnoi |
Subharti Medical College & Hospital |
NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh 250005
Meerut
UTTAR PRADESH |
9643707691
dr.vishal.vishnoi@gmail.com |
| Dr Sourabh Kumar Jain |
The Medicity Hospital |
Teen Pani Kichha Road, Rudrapur, Udham Singh Nagar, Uttarakhand 263153
Rudraprayag
UTTARANCHAL |
7879281577
drsourabh1984@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ikon Ethics Committee for Research on Human Subject |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee for Moti Lal Nehru College |
Approved |
| Institutional Ethics Committee Sparsh Hospital |
Not Applicable |
| V3 Healthcare Private Limited |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F688||Other specified disorders of adultpersonality and behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| 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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 80 years.
2. Documented diagnosis of the basic neurological condition associated with sialorrhea in subjects with Parkinson disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration, or progressive supranuclear palsy) or after stroke or traumatic brain injury.
3. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points with onset at least 6 months before screening.
4. A score of at least 2 points for each item of the DSFS.
5. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson Disease (mROMP) (Section III Drooling, Item A) at screening and baseline.
6. No clinically relevant dysphagia mROMP Swallowing Symptoms Item A score is equal to or less than 2 and is equal to or less than 3 on Item C at screening and baseline.
7. No infection or inflammation in the planned injection sites.
8. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
9. Subject willing and able to comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Non-neurological secondary causes of sialorrhea.
2. Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the study.
3. Recent (i.e., four weeks) drug treatment for sialorrhea.
4. History of recurrent aspiration pneumonia.
5. Extremely poor dental/oral condition as assessed by a qualified dentist.
6. Recent treatment with known hypersensitivity to Botulinum toxin or known hypersensitivity to any ingredient of the study preparation. (If the patient has received treatment within a year for sialorrhea or within 14 weeks for other indications)
7. Recent (i.e., four weeks) changes in anti-parkinsonian medication.
8. Previous or planned surgery or irradiation to control sialorrhea.
9. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. 10. 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 |
The change from baseline will be analyzed using a repeated measure analysis of variance model. The summary statistics will include n, mean, median, standard deviation, minimum and maximum.
Incidence of AEs, Incidence rates of TEAEs and SAEs. Numbers of AEs, SAEs, TEAEs will be tabulated using available version of MedDRA, preferred term, system organ class, severity and relationship. Multiple occurrences of an adverse event will be counted once in that group. |
1. Change in Unstimulated Salivary Flow (uSFR) Rate at baseline and Week 4, 8 and 12.
2. Patients and Investigators Global Impression of Change Scale (GICS) at Baseline, Week 4, 8 and 12.
3. Drooling severity and Frequency Scale scores (DSFS) from screening, baseline, week 4, 8 and 12.
4. Changes in EQ-5D-3L quality of life Questionnaire from screening, baseline, week 4, 8 and 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Intra-glandular injection of XEOMIN (Clostridium Botulinum neurotoxin type A) in the management of sialorrhea in Indian adult population. |
1. Change in Unstimulated Salivary Flow (uSFR) Rate at baseline and Week 4, 8 and 12. (Appendix B)
2. Patients and Investigators Global Impression of Change Scale (GICS) at Baseline, Week 4, 8 and 12(Appendix C)
3. Drooling severity and Frequency Scale scores (DSFS) from screening, baseline, week 4, 8 and 12 (Appendix D)
4. Changes in EQ-5D-3L quality of life Questionnaire from screening, baseline, week 4, 8 and 12. (Appendix E) |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
27/10/2025 |
| 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
Modification(s)
|
The primary goal of this study is to evaluate the safety of injecting XEOMIN (a form of botulinum toxin type A) directly into the salivary glands to treat excessive drooling (sialorrhea) in Indian adults with neurological conditions. Safety will be measured by tracking any adverse events, including treatment-related and serious side effects, throughout the study period. Participants who are unable to visit the clinic as scheduled will still be followed up via phone calls to ensure safety monitoring continues. The secondary goal is to assess how well the treatment works in reducing drooling. This will be evaluated by measuring changes in saliva flow, severity and frequency of drooling, and overall impressions of improvement by both patients and doctors. The study will also track changes in quality of life using standard questionnaires, with assessments taking place at multiple time points: the start of the study, and at weeks 4, 8, and 12. |