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Search / Trial NCT05216250

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

Launched by ABBVIE · Jan 19, 2022

Trial Information

Current as of July 03, 2025

Completed

Keywords

Upper Limb Essential Tremor Ul Et Botox Botulinum Toxin Type A

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Abbvie

AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.

Locations

Hoover, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Loma Linda, California, United States

Aurora, Colorado, United States

Stamford, Connecticut, United States

Boca Raton, Florida, United States

Fernandina Beach, Florida, United States

Jacksonville Beach, Florida, United States

Port Saint Lucie, Florida, United States

Winter Park, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Kansas City, Kansas, United States

Overland Park, Kansas, United States

Boston, Massachusetts, United States

Burlington, Massachusetts, United States

Jackson, Michigan, United States

Columbia, Missouri, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Winston Salem, North Carolina, United States

Centerville, Ohio, United States

New Albany, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Georgetown, Texas, United States

Houston, Texas, United States

Falls Church, Virginia, United States

Crab Orchard, West Virginia, United States

Marshfield, Wisconsin, United States

Milwaukee, Wisconsin, United States

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Westmount, Quebec, Canada

Dallas, Texas, United States

San Antonio, Texas, United States

Montreal, Quebec, Canada

Greenfield, Wisconsin, United States

Jacksonville, Florida, United States

Stamford, Connecticut, United States

Houston, Texas, United States

Boston, Massachusetts, United States

Amherst, New York, United States

Phoenix, Arizona, United States

Orlando, Florida, United States

Burlington, Massachusetts, United States

Winston Salem, North Carolina, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Phoenix, Arizona, United States

Amherst, New York, United States

Patients applied

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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