Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm
Sponsor: Merz Pharmaceuticals GmbH
Summary
The purpose of this study is to determine whether a single treatment with NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the motor-dominant arm (Unilateral Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following treatment cycle will investigate the safety and tolerability of two-sided treatment with NT 201 (botulinum toxin) (Open Label Bilateral Period). All participants will receive NT 201 treatment.
Official title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT 201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2021-02-24
Completion Date
2023-11-21
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Locations (14)
USF, Department of Neurology, Merz Investigational Site #0010020
Tampa, Florida, United States
University of Nebraska Medical Center, Merz Investigational Site #0010269
Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457
Las Vegas, Nevada, United States
Mount Sinai Medical Center, Merz Investigational Site #0010191
New York, New York, United States
Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206
Nashville, Tennessee, United States
Houston Methodist Neurological Institute, Merz Investigational Site #0010226
Houston, Texas, United States
Medstar Georgetown Neurology, Merz Investigational Site #0010231
McLean, Virginia, United States
UW Medical Center - Montlake, Merz Investigational Site #0010450
Seattle, Washington, United States
Selkirk Neurology, Merz Investigational Site #0010456
Spokane, Washington, United States
London Health Sciences Centre, Merz Investigational Site #0010087
London, Ontario, Canada
Specjalistyczne Gabinety, Merz Investigational Site #0480059
Krakow, Poland
NeuroKlinika Gabinet Lekarski, Merz Investigational Site #0480101
Lodz, Poland
Instytut Zdrowia Dr. Boczarska-Jedynak
Oświęcim, Poland
Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064
Warsaw, Poland