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
NCT ID: NCT04766723
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2021-02-24
2023-11-20
Brief Summary
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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 Bliaterial Period). All participants will receive NT 201 treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
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.
NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Interventions
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NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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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
Countries
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Other Identifiers
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2021-001988-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M602011069
Identifier Type: -
Identifier Source: org_study_id
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