Recruiting
Phase 2

AGN-151607-DP

Sponsor:

AbbVie

Code:

NCT07673107

Conditions

Upper Limb Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AGN-151607-DP

Placebo for AGN-151607-DP

Study Details

Brief 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.

Conditions

Upper Limb Essential Tremor

Study ID

NCT07673107

Start date

Jun 18, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AGN-151607-DP

Participants will receive AGN-151607-DP.

placebo comparator: Placebo for AGN-151607-DP

Participants will receive Placebo for AGN-151607-DP.

Interventions

AGN-151607-DP

Intramuscular Injection

Placebo for AGN-151607-DP

Intramuscular Injection

Primary outcome measure

  • Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: 72 weeks ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: 72 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Neuro Pain Research Center /ID# 277899

Recruiting

Fresno, California, United States, 93710

Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079

Recruiting

Boca Raton, Florida, United States, 33486

Charter Research - Winter Park /ID# 277875

Recruiting

Orlando, Florida, United States, 32803-1839

More Information

Sponsor

AbbVie

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Upper Limb Essential Tremor
  • AGN-151607-DP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-29.