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Clinical Trials/EUCTR2015-000682-30-EE
EUCTR2015-000682-30-EE
Active, Not Recruiting
Phase 1

Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases

Tartu University Hospital0 sites90 target enrollmentApril 16, 2015
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ConditionsHypersalivationMedDRA version: 18.0Level: LLTClassification code 10020746Term: HypersalivationSystem Organ Class: 100000004856Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypersalivation
Sponsor
Tartu University Hospital
Enrollment
90
Status
Active, Not Recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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:

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.

Outcomes

Primary Outcomes

Not specified

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