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Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Sponsor: AbbVie
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. 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.
Official title: A Phase 2b Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Treatment of Upper Limb Essential Tremor in Adults
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-06-23
Completion Date
2028-11
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
AGN-151607-DP
Intramuscular Injection
Placebo for AGN-151607-DP
Intramuscular Injection
Locations (21)
The Neurology Center of Southern California - Carlsbad /ID# 278194
Carlsbad, California, United States
Neuro Pain Research Center /ID# 277899
Fresno, California, United States
Neurology Center Of North Orange County /ID# 278490
Fullerton, California, United States
New England Institute for Clinical Research /ID# 277315
Stamford, Connecticut, United States
Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
Boca Raton, Florida, United States
Charter Research - Winter Park /ID# 277875
Orlando, Florida, United States
Emerald Coast Neurology /ID# 277898
Pensacola, Florida, United States
Kansas Institute of Research /ID# 277068
Overland Park, Kansas, United States
Dent Neurologic Institute - Amherst /ID# 277242
Amherst, New York, United States
True North Neurology /ID# 278118
Commack, New York, United States
Neurology - Triad /ID# 277088
Winston-Salem, North Carolina, United States
Mount Carmel Health System /ID# 278234
New Albany, Ohio, United States
Veracity Neuroscience /ID# 277081
Memphis, Tennessee, United States
Texas Neurology /ID# 277067
Dallas, Texas, United States
Lone Star Neurology /ID# 278266
Frisco, Texas, United States
Houston Methodist Hospital /ID# 277326
Houston, Texas, United States
University of Virginia /ID# 278191
Charlottesville, Virginia, United States
Inland Northwest Research /ID# 277077
Spokane, Washington, United States
Center For Neurological Disorders /ID# 277048
Greenfield, Wisconsin, United States
Centre de Recherche St-Louis /ID# 277106
Lévis, Quebec, Canada
Genge Partners /ID# 277096
Pointe-Claire, Quebec, Canada