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

Conditions

• Upper Limb Essential Tremor

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• AGN-151607-DP — DRUG
  Intramuscular Injection
• Placebo for AGN-151607-DP — DRUG
  Intramuscular Injection

Study Details

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.

Key Dates

Start date

Jun 18, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

94 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: 72 weeks ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (3)

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