Recruiting

NCT Number: NCT07673107

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

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.

Recruiting

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Key information

Conditions

Upper Limb Essential Tremor

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neuro Pain Research Center /ID# 277899, Fresno, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

AGN-151607-DP

Drug

Intramuscular Injection

Placebo for AGN-151607-DP

Drug

Intramuscular Injection

Primary outcomes

Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)

Time frame: 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)

Time frame: 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.

Secondary outcomes

Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL)

Time frame: 72 weeks

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.
Change From Baseline in Clinical Global Impression of Severity (CGIS)

Time frame: 72 weeks

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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 29, 2026
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.