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
- Conditions
- Essential Tremor of the Upper Limb
- Interventions
- Drug: NT 201Drug: Placebo
- Registration Number
- NCT04766723
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo NT 201 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. NT 201 (IncobotulinumtoxinA, Xeomin) NT 201 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 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.
- Primary Outcome Measures
Name Time Method Change from study baseline to Week 6 in maximum tremor amplitude measurement at wrist level during the unilateral treatment period From baseline to week 6
- Secondary Outcome Measures
Name Time Method Change from study baseline to Week 6 in TETRAS ADL Functional Impact score From baseline to week 6 Investigator´s Global Impression of Change Scale [GICS] score of motor dominant UL at Week 6 Week 6 Incidence of treatment-emergent AEs [TEAEs] related to treatment From baseline to week 36 Change from study baseline to Week 6 in TETRAS Activities of Daily Living [ADL] UL score From baseline to week 6 Change from Cycle 2 baseline to Week 6 in TETRAS Performance subscale score Week 24 to week 36 Change from Cycle 2 baseline to Week 6 in TETRAS Performance dominant UL score Week 24 to week 36 Change from study baseline to Week 6 in the Essential Tremor Rating Assessment Scale [TETRAS] Performance dominant upper limb [UL] score From baseline to week 6 Change from Cycle 2 baseline to Week 6 in TETRAS ADL UL score Week 24 to week 36 Change from Cycle 2 baseline to Week 6 in TETRAS ADL Functional Impact score Week 24 to week 36 Subject´s Global Impression of Change Scale [GICS] score of motor dominant UL at Week 6 Week 6
Trial Locations
- Locations (14)
Mount Sinai Medical Center, Merz Investigational Site #0010191
🇺🇸New York, New York, United States
Medstar Georgetown Neurology, Merz Investigational Site #0010231
🇺🇸McLean, Virginia, United States
London Health Sciences Centre, Merz Investigational Site #0010087
🇨🇦London, Ontario, Canada
Selkirk Neurology, Merz Investigational Site #0010456
🇺🇸Spokane, Washington, United States
Specjalistyczne Gabinety, Merz Investigational Site #0480059
🇵🇱Krakow, Poland
Houston Methodist Neurological Institute, Merz Investigational Site #0010226
🇺🇸Houston, Texas, United States
UW Medical Center - Montlake, Merz Investigational Site #0010450
🇺🇸Seattle, Washington, United States
Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064
🇵🇱Warsaw, Poland
Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457
🇺🇸Las Vegas, Nevada, United States
University of Nebraska Medical Center, Merz Investigational Site #0010269
🇺🇸Omaha, Nebraska, United States
Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206
🇺🇸Nashville, Tennessee, United States
Instytut Zdrowia Dr. Boczarska-Jedynak
🇵🇱Oświęcim, Poland
USF, Department of Neurology, Merz Investigational Site #0010020
🇺🇸Tampa, Florida, United States
NeuroKlinika Gabinet Lekarski, Merz Investigational Site #0480101
🇵🇱Lodz, Poland