Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Last updated: March 4, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

2

Condition

Essential Tremor

Dystonia

Treatment

BOTOX

Placebo for BOTOX

Clinical Study ID

NCT05216250
M21-471
2021-002191-39
  • Ages 18-80
  • All Genders

Study Summary

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.

  • TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of >= 3 for theTremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than asingle 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 itemscore 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 onat least one of the 3 maneuvers OR

  • TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of > 2 inthe dominant limb

Exclusion

Exclusion Criteria:

  • Any uncontrolled clinically significant medical condition other than the one understudy.

  • Any medical condition that may put the participant at increased risk with exposureto BOTOX Purified Neurotoxin Complex.

Study Design

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: BOTOX
Phase: 2
Study Start date:
April 12, 2022
Estimated Completion Date:
February 03, 2025

Connect with a study center

  • Vancouver Coastal Health Authority - University of British Columbia /ID# 240356

    Vancouver, British Columbia V6T 1Z9
    Canada

    Site Not Available

  • Centricity Research /ID# 240587

    Halifax, Nova Scotia B3S 1N2
    Canada

    Site Not Available

  • Toronto Western Hospital /ID# 231587

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Genge Partners /ID# 251546

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Greene Avenue Clinic /ID# 244376

    Westmount, Quebec H3Z 2A4
    Canada

    Site Not Available

  • Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472

    Hoover, Alabama 35244-5700
    United States

    Site Not Available

  • Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Barrow Neurological Institute /ID# 231731

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • University of Arizona /ID# 239781

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Loma Linda University /ID# 230905

    Loma Linda, California 92354
    United States

    Site Not Available

  • University of Colorado - Anschutz Medical Campus /ID# 239869

    Aurora, Colorado 80045-2527
    United States

    Site Not Available

  • Ki Health Partners, LLC, dba, New England Institute for Clinical Research /ID# 238404

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • New England Institute for Clinical Research /ID# 238404

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Coastal Clinical Research Specialists /ID# 240897

    Fernandina Beach, Florida 32034-4779
    United States

    Site Not Available

  • Coastal Clinical Research Specialists /ID# 240471

    Jacksonville, Florida 32205-8275
    United States

    Site Not Available

  • Coastal Clinical Research Specialists /ID# 240471

    Jacksonville Beach, Florida 32250-1694
    United States

    Site Not Available

  • Charter Research - Winter Park /ID# 241568

    Orlando, Florida 32803-1839
    United States

    Site Not Available

  • CDC Research Institute LLC /ID# 242744

    Port Saint Lucie, Florida 34952-7539
    United States

    Site Not Available

  • Charter Research - Winter Park /ID# 241568

    Winter Park, Florida 32792-6707
    United States

    Site Not Available

  • Emory University / Emory Brain Health Center /ID# 231911

    Atlanta, Georgia 30329-2206
    United States

    Site Not Available

  • Accel Research Site-NeuroStudies /ID# 239881

    Decatur, Georgia 30030-2627
    United States

    Site Not Available

  • Univ Kansas Med Ctr /ID# 231166

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kansas Institute of Research /ID# 231623

    Overland Park, Kansas 66211-1363
    United States

    Site Not Available

  • Tufts Medical Center /ID# 239929

    Boston, Massachusetts 02111-1552
    United States

    Site Not Available

  • Lahey Hospital & Medical Center /ID# 233232

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Lahey Hospital and Medical Center /ID# 233232

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • Henry Ford Health Medical Center - Jackson /ID# 231400

    Jackson, Michigan 49201-1852
    United States

    Site Not Available

  • University of Missouri /ID# 233815

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Dent Neurologic Institute - Amherst /ID# 255665

    Amherst, New York 14226
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc. /ID# 255665

    Amherst, New York 14226
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 231468

    New York, New York 10029
    United States

    Site Not Available

  • UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857

    Chapel Hill, North Carolina 27517-4400
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center /ID# 233550

    Winston-Salem, North Carolina 27157-0001
    United States

    Site Not Available

  • Neurology - Triad /ID# 239806

    Winston-Salem, North Carolina 27103-6984
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center /ID# 233550

    Winston-Salem, North Carolina 27157-0001
    United States

    Active - Recruiting

  • Dayton Center for Neurological Disorders /ID# 233737

    Centerville, Ohio 45459-3811
    United States

    Site Not Available

  • The Orthopedic Foundation /ID# 232234

    New Albany, Ohio 43054-8167
    United States

    Site Not Available

  • Oregon Health & Science University /ID# 231581

    Portland, Oregon 97239-3011
    United States

    Active - Recruiting

  • Oregon Health and Science University /ID# 231581

    Portland, Oregon 97239
    United States

    Site Not Available

  • Thomas Jefferson University /ID# 232614

    Philadelphia, Pennsylvania 19107-4414
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital /ID# 232614

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh MC /ID# 233735

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 233538

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Neurology /ID# 250428

    Dallas, Texas 75214
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center /ID# 239770

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Texas Movement Disorder Specialists, PLLC /ID# 242524

    Georgetown, Texas 78628-4126
    United States

    Site Not Available

  • Baylor College of Medicine - Baylor Medical Center /ID# 231624

    Houston, Texas 77030-3411
    United States

    Active - Recruiting

  • Baylor College of Medicine /ID# 231624

    Houston, Texas 77030
    United States

    Site Not Available

  • Univ Texas HSC San Antonio /ID# 232615

    San Antonio, Texas 78229-3901
    United States

    Site Not Available

  • Integrated Neurology Services - Falls Church /ID# 233545

    Falls Church, Virginia 22043-2367
    United States

    Site Not Available

  • Vaught Neurological Services, PLLC /ID# 234043

    Crab Orchard, West Virginia 25827-9470
    United States

    Site Not Available

  • Gamma Therapeutic Center /ID# 232547

    Greenfield, Wisconsin 53228-1321
    United States

    Site Not Available

  • Marshfield Clinic - Marshfield /ID# 233191

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Gamma Therapeutic Center /ID# 232547

    Milwaukee, Wisconsin 53228-1321
    United States

    Site Not Available

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