Hypersalivation MedDRA version: 18.0 Level: LLT Classification code 10020746 Term: Hypersalivation System Organ Class: 100000004856
Conditions
Interventions
Product Code: Clostridium botulinum type A toxin
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Toxinum Clostridii botulinii
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTI
Sponsors
Tartu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: BNT-A injections into salivary glands is used to treat patients suffering average and hard hypersalivation. • The aetiology of sialorrhea is caused by chronic neurodegenerative diseases. • The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) • The cases when logopedical treatment with chewing muscle and m. orbicularis oris myogymnastics do not decrease the saliva flow. The first control group participants are selected during routine dentist visits at Tartu University Hospital • Requirement is that they have to be healthy human volunteers with the same age group. The second control group are selected during routine neurologist visits. • Parkinson´s disease patients without sialorrhea. The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • During the study, no medication that could influence the severity of drooling is allowed. • Patients with other sialorrhea treatment will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.Evaluate and compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health. 2. Evaluate the BNT-A efficiency in treatment of average and hard sialorrhea patients. 3. Evaluate the BNT-A effect on patients life-quality. ;Secondary Objective: The primary objective is to compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health and to compare thease relates to controls.;Primary end point(s): 1. The study group patients get their BNT-A injections because of sialorhhea treatment despite of investigation. Control groups do not get any BNT-A injections. 2. Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference. 3. Treatment efficacy and safety were assessed with questionnaire at baseline, and at one month after the BNT-A injections follow-up, using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003). 4. Study group will be interviewed by questionnaire twice: before and 1 month after the BNT-A treatment to investigate the changes in life quality. ;Timepoint(s) of evaluation of this end point: Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference.;Timepoint(s) of evaluation of this end point: Treatment efficacy and safety were assessed with questionnaire at baseline, and at one month after the BNT-A injections follow-up, using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003). Study group will be interviewed by questionnaire twice: before and 1 month after the BNT-A treatment to investigate the changes in life quality. | — |
Countries
Estonia
Contacts
Public ContactTartu University Hospital Clinic
Tartu University Hospital Clinic
Outcome results
None listed