Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AGN-151607-DP, Placebo for AGN-151607-DP.
- Who it may be relevant to
- Registry conditions: Upper Limb Essential Tremor. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug AGN-151607-DP
Intramuscular Injection - Drug Placebo for AGN-151607-DP
Intramuscular Injection
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL) [Time frame: 72 weeks]
- Change From Baseline in Clinical Global Impression of Severity (CGIS) [Time frame: 72 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Neuro Pain Research Center /ID# 277899 — Fresno
- Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079 — Boca Raton
- Charter Research - Winter Park /ID# 277875 — Orlando
Identifiers
NCT: NCT07673107 · M25-850