Neurodevelopmental disability associated with hypersalivation MedDRA version: 17.1 Level: PT Classification code 10064062 Term: Neurodevelopmental disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.1 Level: LLT Classification code 10020746 Term: Hypersalivation System Organ Class: 100000004856
Conditions
Sponsors
Colonis Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children (male and female) = 3 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of any medication known to cause hypersalivation 2. Use of glycopyrronium bromide within 24 hours prior to baseline 3. Cholinergic or anticholinergic medications within three plasma half-lives of the medication prior to baseline 4. Intrasalivary gland botulinum toxin within 10 months prior to baseline 5. Intraoral devices or prosthetics for treatment of drooling within 1 week 6. Acupuncture for treatment of drooling within 3 months 7. History of any significant cardiovascular, hepatic, or renal disease 8. Acute illness at the time of either the pre-study medical evaluation or dosing 9. Abnormal and clinically significant laboratory test results 10. Allergy or hypersensitivity to glycopyrronium bromide or other related products 11. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption 12. Medical conditions contraindicating anticholinergic therapy 13. Any other clinically significant abnormality, that in the Investigator’s opinion would put the subject at increased risk of illness or injury, would interfere with study participation, or would interfere with the evaluation or quality of the data 14. Previous enrollment or randomization in this study 15. Participation in another clinical trial with investigational drugs within the last 1 month before screening 16. Pregnant or breastfeeding subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of glycopyrronium bromide in non-drug induced hypersalivation associated with neurodevelopemental disability;Secondary Objective: not applicable;Primary end point(s): Rate of patients showing response from baseline to week 8. Response is defined as a decrease in modified 9-point Teacher’s Drooling Scale (mTDS) by 3 units.;Timepoint(s) of evaluation of this end point: 8th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Longer-term response to glycopyrronium bromide within 24 weeks of administration 2. mTDS at individual time points 3. Global assessment of treatment completed by parent/caregiver and investigator at week 8 and study end· 4. VAS assessment of extent of drooling by parent/caregiver and investigator at each visit;Timepoint(s) of evaluation of this end point: Ad1) 24 th week Ad2) 3times/day during 3 days prior to baseline, then on one day weekly - 3 times/d. Ad 3) Week 8 and week 24 or at withdrawal Ad4) Baseline, week 2, 4, 6, 8, 10,12, 16, 20, 24 or at withdrawal | — |
Countries
Czech Republic, Georgia, Slovakia
Contacts
Public ContactClinical Trials Information
Accord Research, s.r.o.
Outcome results
None listed