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
Key facts
- Who runs it
- Merz Pharmaceuticals GmbH
- Where
- Houston, Las Vegas, McLean, Nashville, New York, Omaha, Seattle, Spokane, and Tampa, United StatesSee the 9 sitesAlso in 2 other countries, 5 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 78 people enrolled
- Started
- 24 Feb 2021
- Ended
- 21 Nov 2023
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NT 201
- Placebo
- Record updated
- 28 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) of the TETRAS performances scale confirmed by an independent TETRAS expert by means of video assessment
Who cannot take part
- 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
Where in United States
Also in 2 other countries, 5 sites
- Houston Methodist Neurological Institute, Merz Investigational Site #0010226Houston, United StatesNo longer taking part
- Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457Las Vegas, United StatesNo longer taking part
- McLean, VirginiaHospital not named in the registryNo longer taking part
- Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206Nashville, United StatesNo longer taking part
- Mount Sinai Medical Center, Merz Investigational Site #0010191New York, United StatesNo longer taking part
- University of Nebraska Medical Center, Merz Investigational Site #0010269Omaha, United StatesNo longer taking part
- UW Medical Center - Montlake, Merz Investigational Site #0010450Seattle, United StatesNo longer taking part
- Spokane, WashingtonHospital not named in the registryNo longer taking part
- USF, Department of Neurology, Merz Investigational Site #0010020Tampa, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- NT 201 (IncobotulinumtoxinA, Xeomin)Treatment being tested
Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular injection of NT 201 (130-165 units) into muscles of the motor-dominant upper limb. Open Label Bilateral Treatment Period (1 treatment cycle): subjects to receive bilateral intramuscular injection of NT 201 (130-165 units) into muscles of both upper limbs.
Treatment: NT 201
- PlaceboPlacebo, for comparison
Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular placebo injection into muscles of the motor-dominant upper limb. Open Label Bilateral Treatment Period (1 treatment cycle): subjects to receive bilateral intramuscular injection of NT 201 (130-165 units per arm) into muscles of both upper limbs.
Treatment: NT 201 and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 28 May 2026