Status:
COMPLETED
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
Lead Sponsor:
AbbVie
Conditions:
Upper Limb Essential Tremor (UL ET)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05216250
Start Date
April 12 2022
End Date
February 3 2025
Last Update
March 5 2025
Active Locations (40)
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1
Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
Hoover, Alabama, United States, 35244-5700
2
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731
Phoenix, Arizona, United States, 85013
3
University of Arizona /ID# 239781
Tucson, Arizona, United States, 85724
4
Loma Linda University /ID# 230905
Loma Linda, California, United States, 92354