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

Completed · Phase 2 · Has a placebo group

Conditions studied: Upper Limb Essential Tremor (UL ET)

In brief

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.

Key facts

Study ID

NCT05216250

Run by

AbbVie

People needed

174

Starts

2022-04-12

Expected to finish

2025-02-03

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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