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

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):

1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points
and

2. A score of at least 2 points for each item of the DSFS and

3. 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.