Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions (SIAXI)
Chronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke
About this trial
This is an interventional treatment trial for Chronic Troublesome Sialorrhea
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); 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 (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice):
- 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.
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.
Sites / Locations
- Merz investigational site #049172
- Merz Investigational Site #049335
- Merz Investigational Site #049337
- Merz Investigational Site #049072
- Merz Investigational Site #049148
- Merz Investigational Site #049300
- Merz Investigational Site #049303
- Merz investigational site #049348
- Merz Investigational Site #049143
- Merz Investigational Site #049333
- Merz Investigational Site #049302
- Merz investigational site #048068
- Merz Investigational Site #048088
- Merz Investigational Site #048029
- Merz investigational site #048074
- Merz investigational site #048078
- Merz investigational site #048076
- Merz investigational site #048077
- Merz investigational Site #048067
- Merz investigational site #048059
- Merz investigational site #048031
- Merz Investigational Site #048087
- Merz Investigational Site #048022
- Merz investigational site #048070
- Merz investigational site #048085
- Merz investigational site #048072
- Merz Investigational Site #048075
- Merz Investigational Site #048086
- Merz investigational site #048065
- Merz investigational site #048056
- Merz investigational site #048064
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IncobotulinumtoxinA (Xeomin) (100 Units)
IncobotulinumtoxinA (Xeomin) (75 Units)
Placebo
Main period (1 treatment cycle): Subjects to receive 100 Units. Extension period (3 treatment cycles): Subjects to receive 100 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)
Main period (1 treatment cycle): Subjects to receive 75 Units. Extension period (3 treatment cycles): Subjects to receive 75 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)
Main period (1 treatment cycle): Subjects to receive placebo injection. Extension period (3 treatment cycles): Subjects will be randomized to receive either 75 or 100 Units IncobotulinumtoxinA per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)