Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1 Level: PT Classification code 10039424 Term: Salivary hypersecretion System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Xeomin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: NT 101
CAS Number: 93384-43-1
Current Sponsor code: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Documented diagnosis of the basic neurological condition associated with sialorrhea (with onset at least 6 months before screening); Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening ; A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and a score of at least 2 points for each item of the DSFS and a score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson’s Disease [mROMP], Section ‘III Drooling’, Item A); A score of at most 2 points on the mROMP Section ‘II Swallowing Symptoms’ Item A) and a score of at most 3 points on Item C), at screening and at baseline. 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 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 153
Exclusion criteria
Exclusion criteria: Non-neurological secondary causes of sialorrhea; 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 course of the study; Recent (i.e., four weeks) drug treatment for sialorrhea; History of recurrent aspiration pneumonia; Extremely poor dental/oral condition as assessed by a qualified dentist; Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with – or known hypersensitivity to – Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation; Recent (i.e., four weeks) changes in anti-parkinsonian medication; Previous or planned surgery or irradiation to control sialorrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.;Secondary Objective: not applicable;Primary end point(s): Unstimulated salivary flow rate:Change from baseline to week 4; Subject's GICS entry (rating on the Global Impression of Change Scale; or carer's GICS entry, if the subject is not able to answer): week 4.;Timepoint(s) of evaluation of this end point: 4 weeks after first injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Unstimulated salivary flow rate: Change from baseline to weeks 8 and 12. Subject's GICS entry (or carer's GICS entry, if the subject is not able to answer):weeks 1, 2, 8 and 12.;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 8 and 12 | — |
Countries
Germany, Poland, United States
Outcome results
None listed