Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-151607-DP · 2 trials · 2 indications
TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| AGN-151607-DP | EXPERIMENTAL | Participants will receive AGN-151607-DP. |
| Placebo for AGN-151607-DP | PLACEBO_COMPARATOR | Participants will receive Placebo for AGN-151607-DP. |
| AGN-151607-DP Dose A | EXPERIMENTAL | Participants will receive AGN-151607-DP Dose A on Day 1. |
| AGN-151607-DP Dose B | EXPERIMENTAL | Participants will receive AGN-151607-DP Dose B on Day 1. |
| AGN-151607-DP Dose C | EXPERIMENTAL | Participants will receive AGN-151607-DP Dose C on Day 1. |
| Name | Type | Description |
|---|---|---|
| AGN-151607-DP | DRUG | Intramuscular Injection |
| Placebo for AGN-151607-DP | DRUG | Intramuscular Injection |
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 fore...
AGN-151607-DP is an investigational small molecule being studied for two conditions: upper limb essential tremor and ventral hernia. It is in Phase 2 clinical development for both indications.
AGN-151607-DP is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
AGN-151607-DP is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are currently recruiting participants in the United States.
AGN-151607-DP is being evaluated in two Phase 2 trials. NCT07226791 is studying the drug in adults undergoing open abdominal ventral hernia repair with an enrollment of 200 participants. NCT07673107 is studying the drug in adults with upper limb essential tremor with an enrollment of 94 participants. Both trials are recruiting in the United States.
No alternative names for AGN-151607-DP have been disclosed. It is identified solely by its development code AGN-151607-DP in clinical trial registrations.