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
Essential Tremor of the Upper Limb
About this trial
This is an interventional treatment trial for Essential Tremor of the Upper Limb
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- USF, Department of Neurology, Merz Investigational Site #0010020
- University of Nebraska Medical Center, Merz Investigational Site #0010269
- Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457
- Mount Sinai Medical Center, Merz Investigational Site #0010191
- Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206
- Houston Methodist Neurological Institute, Merz Investigational Site #0010226
- Medstar Georgetown Neurology, Merz Investigational Site #0010231
- UW Medical Center - Montlake, Merz Investigational Site #0010450
- Selkirk Neurology, Merz Investigational Site #0010456
- London Health Sciences Centre, Merz Investigational Site #0010087
- Specjalistyczne Gabinety, Merz Investigational Site #0480059
- NeuroKlinika Gabinet Lekarski, Merz Investigational Site #0480101
- Instytut Zdrowia Dr. Boczarska-Jedynak
- Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
NT 201 (IncobotulinumtoxinA, Xeomin)
Placebo
Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular injection of NT 201 (130-165 units) into muscles of the 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 the upper limbs.
Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular placebo injection into muscles of the 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 the upper limbs.