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
Who is this study for? Patients with Essential Tremor of the Upper Limb
What treatments are being studied? NT 201
Status: Completed
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 the 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 Bliaterial Period). All participants will receive NT 201 treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- 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.
Locations
United States
Florida
USF, Department of Neurology, Merz Investigational Site #0010020
Tampa
Nebraska
University of Nebraska Medical Center, Merz Investigational Site #0010269
Omaha
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457
Las Vegas
New York
Mount Sinai Medical Center, Merz Investigational Site #0010191
New York
Tennessee
Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206
Nashville
Texas
Houston Methodist Neurological Institute, Merz Investigational Site #0010226
Houston
Virginia
Medstar Georgetown Neurology, Merz Investigational Site #0010231
Mclean
Washington
UW Medical Center - Montlake, Merz Investigational Site #0010450
Seattle
Selkirk Neurology, Merz Investigational Site #0010456
Spokane
Other Locations
Canada
London Health Sciences Centre, Merz Investigational Site #0010087
London
Poland
Specjalistyczne Gabinety, Merz Investigational Site #0480059
Krakow
NeuroKlinika Gabinet Lekarski, Merz Investigational Site #0480101
Lodz
Instytut Zdrowia Dr. Boczarska-Jedynak
Oświęcim
Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064
Warsaw
Time Frame
Start Date:2021-02-24
Completion Date:2023-11-20
Participants
Target number of participants:78
Treatments
Experimental: NT 201 (IncobotulinumtoxinA, Xeomin)
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.
Placebo_comparator: Placebo
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.