Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
NCT ID: NCT05216250
Last Updated: 2026-01-20
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
174 participants
INTERVENTIONAL
2022-04-12
2025-02-03
Brief Summary
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BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America.
Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BOTOX/BOTOX Unilateral
Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3
BOTOX
Intramuscular injection
BOTOX/BOTOX Bilateral
Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3
BOTOX
Intramuscular injection
Placebo/BOTOX Unilateral
Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3.
BOTOX
Intramuscular injection
Placebo for BOTOX
Intramuscular injection
Placebo/BOTOX Bilateral
Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3.
BOTOX
Intramuscular injection
Placebo for BOTOX
Intramuscular injection
Interventions
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BOTOX
Intramuscular injection
Placebo for BOTOX
Intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of \>= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.
* TETRAS activities of daily living (ADL) (recorded on a 0-4 scale, whole numbers) minimum score of \>= 3 on any of the 5 unilateral items; no more than a single item score of \<=1 among the 5 unilateral items in the dominant limb.
* At least one of the following criteria must also be met:
* TETRAS UL score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb on at least one of the 3 maneuvers OR
* TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb
Exclusion Criteria
* Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.
18 Years
80 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
Hoover, Alabama, United States
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731
Phoenix, Arizona, United States
University of Arizona /ID# 239781
Tucson, Arizona, United States
Loma Linda University /ID# 230905
Loma Linda, California, United States
University of Colorado - Anschutz Medical Campus /ID# 239869
Aurora, Colorado, United States
New England Institute for Clinical Research /ID# 238404
Stamford, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677
Boca Raton, Florida, United States
Coastal Clinical Research Specialists /ID# 240897
Fernandina Beach, Florida, United States
Coastal Clinical Research Specialists /ID# 240471
Jacksonville, Florida, United States
Charter Research - Winter Park /ID# 241568
Orlando, Florida, United States
CDC Research Institute LLC /ID# 242744
Port Saint Lucie, Florida, United States
Emory University / Emory Brain Health Center /ID# 231911
Atlanta, Georgia, United States
Accel Research Site-NeuroStudies /ID# 239881
Decatur, Georgia, United States
Univ Kansas Med Ctr /ID# 231166
Kansas City, Kansas, United States
Kansas Institute of Research /ID# 231623
Overland Park, Kansas, United States
Tufts Medical Center /ID# 239929
Boston, Massachusetts, United States
Lahey Hospital & Medical Center /ID# 233232
Burlington, Massachusetts, United States
Henry Ford Health Medical Center - Jackson /ID# 231400
Jackson, Michigan, United States
Dent Neurologic Institute - Amherst /ID# 255665
Amherst, New York, United States
UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857
Chapel Hill, North Carolina, United States
Neurology - Triad /ID# 239806
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 233550
Winston-Salem, North Carolina, United States
Dayton Center for Neurological Disorders /ID# 233737
Centerville, Ohio, United States
The Orthopedic Foundation /ID# 232234
New Albany, Ohio, United States
Oregon Health and Science University /ID# 231581
Portland, Oregon, United States
Thomas Jefferson University Hospital /ID# 232614
Philadelphia, Pennsylvania, United States
University of Pittsburgh MC /ID# 233735
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina /ID# 233538
Charleston, South Carolina, United States
Texas Neurology /ID# 250428
Dallas, Texas, United States
University of Texas Southwestern Medical Center /ID# 239770
Dallas, Texas, United States
Texas Movement Disorder Specialists, PLLC /ID# 242524
Georgetown, Texas, United States
Baylor College of Medicine /ID# 231624
Houston, Texas, United States
Univ Texas HSC San Antonio /ID# 232615
San Antonio, Texas, United States
Integrated Neurology Services - Falls Church /ID# 233545
Falls Church, Virginia, United States
Gamma Therapeutic Center /ID# 232547
Greenfield, Wisconsin, United States
Marshfield Clinic - Marshfield /ID# 233191
Marshfield, Wisconsin, United States
Vancouver Coastal Health Authority - University of British Columbia /ID# 240356
Vancouver, British Columbia, Canada
Centricity Research /ID# 240587
Halifax, Nova Scotia, Canada
Toronto Western Hospital /ID# 231587
Toronto, Ontario, Canada
Genge Partners /ID# 251546
Montreal, Quebec, Canada
Countries
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Related Links
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Other Identifiers
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2021-002191-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M21-471
Identifier Type: -
Identifier Source: org_study_id
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