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 23, 2026

Status verified date

Oct, 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

The Neurology Center of Southern California - Carlsbad /ID# 278194

Recruiting

Carlsbad, California, United States, 92011

Neuro Pain Research Center /ID# 277899

Recruiting

Fresno, California, United States, 93710

Neurology Center Of North Orange County /ID# 278490

Recruiting

Fullerton, California, United States, 92835

New England Institute for Clinical Research /ID# 277315

Recruiting

Stamford, Connecticut, United States, 06905

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

Emerald Coast Neurology /ID# 277898

Recruiting

Pensacola, Florida, United States, 32504-8649

Kansas Institute of Research /ID# 277068

Recruiting

Overland Park, Kansas, United States, 66211-1358

Dent Neurologic Institute - Amherst /ID# 277242

Recruiting

Amherst, New York, United States, 14226

True North Neurology /ID# 278118

Recruiting

Commack, New York, United States, 11725

Neurology - Triad /ID# 277088

Recruiting

Winston-Salem, North Carolina, United States, 27103

Veracity Neuroscience /ID# 277081

Recruiting

Memphis, Tennessee, United States, 38157

Texas Neurology /ID# 277067

Recruiting

Dallas, Texas, United States, 75206-5202

Lone Star Neurology /ID# 278266

Recruiting

Frisco, Texas, United States, 75035

Houston Methodist Hospital /ID# 277326

Recruiting

Houston, Texas, United States, 77030

University of Virginia /ID# 278191

Recruiting

Charlottesville, Virginia, United States, 22908

Inland Northwest Research /ID# 277077

Recruiting

Spokane, Washington, United States, 99202

Center For Neurological Disorders /ID# 277048

Recruiting

Greenfield, Wisconsin, United States, 53228

Centre de Recherche St-Louis /ID# 277106

Recruiting

Lévis, Quebec, Canada, G6W 0M5

Genge Partners /ID# 277096

Recruiting

Pointe-Claire, Quebec, Canada, H9R 4Y2

More Information

Sponsor

AbbVie

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Upper Limb Essential Tremor
  • AGN-151607-DP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.