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

Completed · Phase 2 · Has a placebo group

Conditions studied: Essential Tremor of the Upper Limb

In brief

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.

Key facts

Study ID

NCT04766723

Run by

Merz Pharmaceuticals GmbH

People needed

78

Starts

2021-02-24

Expected to finish

2023-11-21

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• 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

Full record on ClinicalTrials.gov

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