Medication AGN-151607-DP to help upper limb tremor in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 trial, adults with upper limb essential tremor are randomly assigned to receive either AGN-151607-DP or a matching placebo via intramuscular injections over about 72 weeks. Researchers monitor safety by recording adverse events and track changes in tremor severity using questionnaires and clinical assessments. Approximately 94 participants will be enrolled across about 40 sites in the United States and Canada. The study aims to determine if the drug can reduce disease activity without unacceptable side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Neurology Center of Southern California - Carlsbad /ID# 278194
  Carlsbad, California, United States Recruiting
• Neuro Pain Research Center /ID# 277899
  Fresno, California, United States Recruiting
• Neurology Center Of North Orange County /ID# 278490
  Fullerton, California, United States Recruiting
• New England Institute for Clinical Research /ID# 277315
  Stamford, Connecticut, United States Recruiting
• Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
  Boca Raton, Florida, United States Recruiting
• Charter Research - Winter Park /ID# 277875
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.