Clinical trial
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT…
NCT02091739 · Merz Pharmaceuticals GmbH, Industry · Completed
Key facts
| NCT number | NCT02091739 |
|---|---|
| Title | 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 |
| Official title | Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions |
| Acronym | SIAXI |
| Lead sponsor | Merz Pharmaceuticals GmbH, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Chronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke, Traumatic Brain Injury |
| Intervention type | Drug |
| Interventions | IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units), Placebo |
| Enrollment | 184 |
| Start date | Apr 1, 2014 |
| Primary completion | Aug 1, 2015 |
| Completion | Nov 1, 2016 |
| First posted | Mar 19, 2014 |
| Last update posted | Mar 27, 2018 |
| Countries | Germany, Poland |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: