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

Study Identifier
M21-471
CT.gov Identifier
NCT05216250
EudraCT Identifier
2021-002191-39
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Essential Tremor
    • Study Drug
  • BOTOX
  • Placebo for BOTOX
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    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 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 uncontrolled clinically significant medical condition other than the one under study. * Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
    Hoover, Alabama, United States, 35244-5700
    Status
    Not applicable
    Location
    Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    University of Arizona /ID# 239781
    Tucson, Arizona, United States, 85724
    Status
    Not applicable
    Location
    Loma Linda University /ID# 230905
    Loma Linda, California, United States, 92354
    Status
    Not applicable
    Location
    University of Colorado - Anschutz Medical Campus /ID# 239869
    Aurora, Colorado, United States, 80045-2527
    Status
    Not applicable
    Location
    New England Institute for Clinical Research /ID# 238404
    Stamford, Connecticut, United States, 06905
    Status
    Not applicable
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