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
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.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-08
- Completion
- 2016-11
Outcome
Met primary endpoint
registry analysis (superiority test); MP: Placebo vs MP: IncobotulinumtoxinA (Xeomin) (100 Units); p = 0.004; LS mean difference -0.09 (95% CI -0.15 to 0.03); MMRM NCT02091739 ↗
registry analysis (superiority test); MP: Placebo vs MP: IncobotulinumtoxinA (Xeomin) (100 Units); p = 0.002; LS mean difference 0.58 (95% CI 0.22 to 0.94); MMRM NCT02091739 ↗
paper Patients' Global Impression of Change Scale scores also improved at week 4, with a significant difference vs placebo in the incobotulinumtoxinA 100 U group (p = 0.002). PMID 30918101 ↗
Publications
- Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baque B, Dorsch U, Csikos J, Blitzer A. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism Relat Disord. 2020 Jan;70:23-30. doi: 10.1016/j.parkreldis.2019.11.024. Epub 2019 Nov 26.
- Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baque B, Csikos J, Cairney CJ, Blitzer A. SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea. Neurology. 2019 Apr 23;92(17):e1982-e1991. doi: 10.1212/WNL.0000000000007368. Epub 2019 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 75 iu | Other |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |