Phase 3
Completed N=184
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
Source: ClinicalTrials.gov NCT02091739 ↗Enrolled (actual)
184
Serious AEs
13.2%
Results posted
Feb 2018
Primary outcomePrimary: MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 — -0.04; -0.06; -0.13 gram per minute (g/min) — p== 0.004
◆ Published Evidence
Highly cited
121citations · ~17 / year
SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea.
Summary
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.
Linked Publications (2)
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SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea.
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Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 |
-0.04; -0.06; -0.13 | = 0.004 sig |
| PRIMARY MP: Participant's Global Impression of Change Scale (GICS) at Week 4 |
0.67; 1.02; 1.25 | = 0.002 sig |
| SECONDARY MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 |
-0.02; -0.08; -0.13; -0.03; -0.1; -0.12 | — |
| SECONDARY MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 |
0.67; 0.73; 0.96; 0.83; 0.91; 1.11 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02091739) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.