Trials / Completed
CompletedNCT02270736
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Children and Adolescents (2-17 Years) With Chronic Troublesome Sialorrhea Associated With Neurological Disorders, and/or Intellectual Disability
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NT 201 Placebo | NT 201 placebo matching injection. |
| DRUG | NT 201 | NT 201 injection. |
Timeline
- Start date
- 2015-02-09
- Primary completion
- 2018-02-23
- Completion
- 2019-05-07
- First posted
- 2014-10-21
- Last updated
- 2021-08-10
- Results posted
- 2021-01-20
Locations
31 sites across 6 countries: Georgia, Hungary, Poland, Russia, Serbia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02270736. Inclusion in this directory is not an endorsement.