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

RecruitingPhase 2Ages 18 Years - 85 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 effect

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • AGN-151607-DP
  • Placebo for AGN-151607-DP
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Where

20 sites
The Neurology Center of Southern California - Carlsbad /ID# 278194
Carlsbad, United States
Neuro Pain Research Center /ID# 277899
Fresno, United States
Neurology Center Of North Orange County /ID# 278490
Fullerton, United States
New England Institute for Clinical Research /ID# 277315
Stamford, United States
Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
Boca Raton, United States
Charter Research - Winter Park /ID# 277875
Orlando, United States
Emerald Coast Neurology /ID# 277898
Pensacola, United States
Kansas Institute of Research /ID# 277068
Overland Park, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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