NCT07673107 Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
| NCT ID | NCT07673107 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AbbVie |
| Condition | Upper Limb Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2026-06-18 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 94 participants in total. It began in 2026-06-18 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT07673107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Upper Limb Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07673107 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07673107 currently recruiting?
Yes, NCT07673107 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT07673107 trial being conducted?
This trial is being conducted at Fresno, United States, Boca Raton, United States, Orlando, United States.
Who is sponsoring the NCT07673107 clinical trial?
NCT07673107 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 94 participants.