Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Key facts
- Where
- Amherst, Boca Raton, Carlsbad, Charlottesville, Commack, Dallas, Fresno, Frisco, Fullerton, Greenfield, Houston, Memphis, New Albany, Orlando, Overland Park, Pensacola, Spokane, Stamford, and Winston-Salem, United StatesSee the 19 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07673107, who can take part
Where in United States
- Dent Neurologic Institute - Amherst /ID# 277242Amherst, United StatesTaking people
- Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079Boca Raton, United StatesTaking people
- The Neurology Center of Southern California - Carlsbad /ID# 278194Carlsbad, United StatesTaking people
- University of Virginia /ID# 278191Charlottesville, United StatesTaking people
- True North Neurology /ID# 278118Commack, United StatesTaking people
- Texas Neurology /ID# 277067Dallas, United StatesTaking people
- Neuro Pain Research Center /ID# 277899Fresno, United StatesTaking people
- Lone Star Neurology /ID# 278266Frisco, United StatesTaking people
- Neurology Center Of North Orange County /ID# 278490Fullerton, United StatesTaking people
- Center For Neurological Disorders /ID# 277048Greenfield, United StatesTaking people
- Houston Methodist Hospital /ID# 277326Houston, United StatesTaking people
- Veracity Neuroscience /ID# 277081Memphis, United StatesTaking people
- Mount Carmel Health System /ID# 278234New Albany, United StatesTaking people
- Charter Research - Winter Park /ID# 277875Orlando, United StatesTaking people
- Kansas Institute of Research /ID# 277068Overland Park, United StatesTaking people
- Emerald Coast Neurology /ID# 277898Pensacola, United StatesTaking people
- Inland Northwest Research /ID# 277077Spokane, United StatesTaking people
- New England Institute for Clinical Research /ID# 277315Stamford, United StatesTaking people
- Neurology - Triad /ID# 277088Winston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AbbVie
- Trial code
- NCT07673107
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Minimum body weight of 50 kg (110 pounds) at Screening; Diagnosis of essential tremor (ET) in accordance with the modified Tremor Research Investigation Group (TRIG) criteria, as follows:; Bilateral postural tremor with or without kinetic tremor, involving hands and forearms; Tremor of other body parts may or may not be present in addition to upper limb (UL) tremor; Bilateral tremor may or may not be asymmetric; Tremor that is reported by the participant to be persistent, although the amplitude may fluctuate.
Exclusion: History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular junctional disorders; History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and/or other botulinum toxins.