Status:
COMPLETED
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
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Essential Tremor of the Upper Limb
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in...
Eligibility Criteria
Inclusion
- \- Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent TETRAS expert by means of video assessment.
Exclusion
- History or presence of day-to-day fluctuations in ET which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on another day.
- Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the ET diagnosis and/or assessment of ET in ULs.
- Tremor types other than ET
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04766723
Start Date
February 24 2021
End Date
November 20 2023
Last Update
April 22 2024
Active Locations (14)
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1
USF, Department of Neurology, Merz Investigational Site #0010020
Tampa, Florida, United States, 33612
2
University of Nebraska Medical Center, Merz Investigational Site #0010269
Omaha, Nebraska, United States, 68131
3
Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457
Las Vegas, Nevada, United States, 89106
4
Mount Sinai Medical Center, Merz Investigational Site #0010191
New York, New York, United States, 10029