Study of Botox for upper limb essential tremor (H-52530)

Essential Tremor: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled study of botox for the treatment of upper limb essential tremor Abbvie M21-471

The purpose of this study is to see if the study drug Onabotulinumtoxin A (BOTOX®), is safe and helps to reduce upper limb essential tremor in adults (18 to 80 years of age) who experienced persistent, bilateral tremor during movement, involving hands and forearms.

This study is being conducted at approximately 40 research centers in 2 countries. Approximately 174 adult men and women with upper limb essential tremor will be selected to participate in this study.

This study is for research purposes only. This study will help the sponsor, AbbVie, to learn about Onabotulinumtoxin A (BOTOX®) safety and effectiveness when compared to placebo (a substance that looks like a drug but has no drug in it) in people experiencing upper limb essential tremor. 

The study drug has been approved by the regulatory authorities to treat specific medical conditions but is not approved to treat upper limb essential tremor. Therefore, the use of the study drug is investigational (experimental) for the purposes of this study.