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

NCT07673107 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: M25-850
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

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

Keywords

Upper Limb Essential Tremor; AGN-151607-DP

Outcome Measures

Primary Outcomes (2)

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

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

  72 weeks

• Number of Participants with Adverse Events (AEs)

  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.

  72 weeks

Secondary Outcomes (2)

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

  72 weeks

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

  72 weeks

Study Arms (2)

AGN-151607-DP

EXPERIMENTAL

Participants will receive AGN-151607-DP.

Drug: AGN-151607-DP

Placebo for AGN-151607-DP

PLACEBO COMPARATOR

Participants will receive Placebo for AGN-151607-DP.

Drug: Placebo for AGN-151607-DP

Interventions

AGN-151607-DP DRUG

Intramuscular Injection

AGN-151607-DP

Placebo for AGN-151607-DP DRUG

Intramuscular Injection

Placebo for AGN-151607-DP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Neuro Pain Research Center /ID# 277899

Fresno, California, 93710, United States

RECRUITING

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

Boca Raton, Florida, 33486, United States

RECRUITING

Charter Research - Winter Park /ID# 277875

Orlando, Florida, 32803-1839, United States

RECRUITING

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (3)