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. This study will assess if AGN-151607-DP is safe and effective by assessing adverse events and change in disease activity in adult participants with UL ET. AGN-151607-DP is an investigational drug being developed to treat UL ET. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 94 adult participants with upper limb essential tremor will be enrolled in approximately 40 sites in the United States/Canada. Participants will receive intramuscular injections of AGN-151607-DP or matching placebo. Duration of the study is approximately 72 weeks. The effect of the treatment will be checked by completion of questionnaires and side effects will be monitored by medical assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
Intramuscular Injection
Intramuscular Injection
Neuro Pain Research Center /ID# 277899
Fresno, California, United States
RECRUITINGParkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
Boca Raton, Florida, United States
RECRUITINGCharter Research - Winter Park /ID# 277875
Orlando, Florida, United States
RECRUITINGChange From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)
TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).
Time frame: 72 weeks
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time frame: 72 weeks
Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL)
TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor. Items are scored from 0 to 4, with 0 indicating no tremor and 4 indicating a severe tremor.
Time frame: 72 weeks
Change From Baseline in Clinical Global Impression of Severity (CGIS)
CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale with scores ranging none to very severe.
Time frame: 72 weeks
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