Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
Age: 18 - 80 years
Healthy Subjects: No
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: April 12, 2022
End Date: November 28, 2023
- Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.
- The Essential Tremor Rating Assessment Scale (TETRAS) upper limit (UL) score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb on at least one of the 3 maneuvers.
- TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) > 2 in the dominant limb.
- 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.
- 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.