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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

NCT02270736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2021-08-10

Study results available
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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

DRUG

NT 201 Placebo

NT 201 placebo matching injection.

DRUG

NT 201

NT 201 injection.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Pharmaceuticals GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-09
Primary Completion
2018-02-23
Completion
2019-05-07
FDA Drug
Yes

Countries

  • Georgia
  • Hungary
  • Poland
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270736 on ClinicalTrials.gov