Study of AGN-151607-DP for Upper Limb Essential Tremor

This study is testing an investigational drug called AGN-151607-DP for adults with upper limb essential tremor (UL ET). UL ET is a movement disorder that causes shaking in the hands and forearms, making everyday tasks difficult. Researchers want to see if AGN-151607-DP is safe and if it can improve tremor symptoms. You could be eligible if you are between 18 and 85 years old, weigh at least 110 pounds, and have been diagnosed with UL ET. Participants will receive either AGN-151607-DP or a placebo (an inactive substance) through intramuscular injections. The study will measure changes in your tremor using a special scale and track any side effects over 72 weeks. Approximately 94 adults will participate across sites in the US and Canada.

Study design
This is an interventional study where participants are randomly assigned to receive either AGN-151607-DP or a placebo. Approximately 94 adult participants will be enrolled.
What's involved
Participants will receive intramuscular injections of either AGN-151607-DP or a placebo. The study will measure changes in tremor and adverse events over 72 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in tremor and adverse events for 72 weeks.

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NCT07673107

Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor

Recruiting
PHASE2Ages 18–85InterventionalTreatment
AbbVie
~94 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:AGN-151607-DPPlacebo for AGN-151607-DP

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)
Measured over 72 weeks
+1 more outcome measured
Upper Limb Essential Tremor
3 sites across 2 states
Florida2
California1
  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

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.
  • Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)72 weeks

    TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).

  • Number of Participants with Adverse Events (AEs)72 weeks

    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.