Study to Assess the Efficacy and Safety of the Glycopyrronium bromide in the Treatment of Non-drug Induced Hypersalivatio

• Conditions: eurodevelopmental disability associated with hypersalivation; MedDRA version: 17.1Level: PTClassification code 10064062Term: Neurodevelopmental disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.1Level: LLTClassification code 10020746Term: HypersalivationSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001631-36-SK
• Lead Sponsor: Colonis Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-18
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Children (male and female) = 3 and < 18 years of age
2. Neurodevelopmental disability associated with hypersalivation; defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week) by confirming the Modified Teacher's Drooling Scale score = 5
3. Weight = 13 kg
4. Female subjects of childbearing potential must have a negative pregnancy test at screening
5. Female subjects of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with the regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 90 days before IMP administration; total abstinence from sexual intercourse; intrauterine device (IUD); double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream). Male subjects must also agree to use acceptable methods of birth control with their female partners, and this may include use of a male condom plus
spermicide.
6. Informed consent signed by both parents or legally acceptable representative and children = 7 years (if the child is able to understand and sign the document)
7. Ability and willingness of children and their parents/caregivers to comply with study requirements, including the visit requirements, study procedures, concomitant medication restrictions and diary completion
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of glycopyrronium bromide in non-drug induced<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Longer-term response to glycopyrronium bromide within 24 weeks of administration<br>2. mTDS at individual time points<br>3. Global assessment of treatment completed by parent/caregiver and investigator at week 8 and study end·<br>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<br>Ad2) 3times/day during 3 days prior to baseline, then on one day weekly - 3 times/d.<br>Ad 3) Week 8 and week 24 or at withdrawal<br>Ad4) Baseline, week 2, 4, 6, 8, 10,12, 16, 20, 24 or at withdrawal