Upper Limb Essential TremorPhase 2NCT07673107
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
A Phase 2 study testing AGN-151607-DP in people with Upper Limb Essential Tremor, run by AbbVie at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Upper Limb Essential Tremor
- What is being tested?
- AGN-151607-DP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 23 Jun 2026to Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 2 countries
United States18 sites, 18 recruiting
- Recruiting
Dent Neurologic Institute - Amherst /ID# 277242
Amherst, New York, 14226
- Recruiting
Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
Boca Raton, Florida, 33486
- Recruiting
The Neurology Center of Southern California - Carlsbad /ID# 278194
Carlsbad, California, 92011
- Recruiting
University of Virginia /ID# 278191
Charlottesville, Virginia, 22908
- Recruiting
True North Neurology /ID# 278118
Commack, New York, 11725
- Recruiting
Texas Neurology /ID# 277067
Dallas, Texas, 75206-5202
- Recruiting
Neuro Pain Research Center /ID# 277899
Fresno, California, 93710
- Recruiting
Lone Star Neurology /ID# 278266
Frisco, Texas, 75035
- Recruiting
Neurology Center Of North Orange County /ID# 278490
Fullerton, California, 92835
- Recruiting
Center For Neurological Disorders /ID# 277048
Greenfield, Wisconsin, 53228
- Recruiting
Houston Methodist Hospital /ID# 277326
Houston, Texas, 77030
- Recruiting
Veracity Neuroscience /ID# 277081
Memphis, Tennessee, 38157
- Recruiting
Charter Research - Winter Park /ID# 277875
Orlando, Florida, 32803-1839
- Recruiting
Kansas Institute of Research /ID# 277068
Overland Park, Kansas, 66211-1358
- Recruiting
Emerald Coast Neurology /ID# 277898
Pensacola, Florida, 32504-8649
- Recruiting
Inland Northwest Research /ID# 277077
Spokane, Washington, 99202
- Recruiting
New England Institute for Clinical Research /ID# 277315
Stamford, Connecticut, 06905
- Recruiting
Neurology - Triad /ID# 277088
Winston-Salem, North Carolina, 27103
Canada2 sites, 2 recruiting
- Recruiting
Centre de Recherche St-Louis /ID# 277106
Lévis, Quebec, G6W 0M5
- Recruiting
Genge Partners /ID# 277096
Pointe-Claire, Quebec, H9R 4Y2
About this study
Official title: A Phase 2b Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Treatment of Upper Limb Essential Tremor in Adults
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.
Read more
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.
- Conditions
- Upper Limb Essential Tremor
- Being tested
- AGN-151607-DP, Placebo for AGN-151607-DP
- Keywords
- Upper Limb Essential Tremor, AGN-151607-DP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151607-DPDrug
Intramuscular Injection
Placebo for AGN-151607-DPDrug
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| AGN-151607-DP | Experimental | Participants will receive AGN-151607-DP. Receives: Drug: AGN-151607-DP |
| Placebo for AGN-151607-DP | Placebo comparator | Participants will receive Placebo for AGN-151607-DP. Receives: Drug: Placebo for AGN-151607-DP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)
TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).
Measured: 72 weeks
Number of Participants with Adverse Events (AEs)
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.
Measured: 72 weeks
Secondary outcomes (2)
Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL)
TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor. Items are scored from 0 to 4, with 0 indicating no tremor and 4 indicating a severe tremor.
Measured: 72 weeks
Change From Baseline in Clinical Global Impression of Severity (CGIS)
CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale with scores ranging none to very severe.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start23 Jun 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Essential TremorStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673107
- Sponsor's protocol ID
- M25-850
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.