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New treatment option for Upper Limb Essential Tremor
Official title Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
ClinicalTrials.gov ID: NCT07673107
What this study is testing
What is AGN-151607-DP?
AGN-151607-DP is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for upper limb essential tremor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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
You likely can't join if
- History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including...
- History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and/or other botulinum toxins.
See the full eligibility 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.
- 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)...
- History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and/or other botulinum toxins.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Boca Raton, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Boca Raton, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.