Health Condition 1: F688- Other specified disorders of adultpersonality and behavior
Conditions
Interventions
Intervention1: 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 1
Sponsors
Modi-Mundipharma Pvt Ltd
CliniExperts Research Services Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| To assess the efficacy of Intra-glandular injection of XEOMIN (Clostridium Botulinum neurotoxin type A) in the management of sialorrhea in Indian adult population.Timepoint: 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) | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt. Ltd.
Outcome results
None listed