BOTOX Injections for Essential Tremor

No longer recruiting at 60 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Uncontrolled conditions, Increased risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of BOTOX injections for treating essential tremor in the arms, a condition that makes daily tasks like writing and eating difficult due to uncontrollable shaking. Participants will be randomly assigned to receive either BOTOX or a placebo in different cycles, with some receiving injections in one arm and others in both arms. The trial aims to determine if BOTOX can reduce tremors and improve quality of life. Individuals diagnosed with essential tremor that disrupts daily activities may be a good fit for this study. Participants must attend regular clinic visits for assessments and monitoring. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BOTOX is generally safe for people, with a well-known safety record. The most common side effect is mild to moderate muscle weakness, which usually resolves quickly. One study found that 24.5% of participants experienced this type of weakness. These findings suggest that while BOTOX is mostly well-tolerated, some individuals may notice temporary muscle weakness after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using BOTOX for essential tremor because it offers a novel approach compared to traditional treatments like beta-blockers or anti-seizure medications. Unlike these medications, which can have systemic side effects, BOTOX works locally by targeting the overactive muscles causing the tremors. This local action may result in fewer side effects and a more tailored response. Additionally, BOTOX's flexible administration options, including unilateral and bilateral injections, allow for personalized treatment plans based on the severity and side of the tremor.

What evidence suggests that this trial's treatments could be effective for essential tremor?

Research has shown that BOTOX may help people with upper limb essential tremor (UL ET). In this trial, participants will receive either BOTOX or a placebo in the initial cycles, followed by BOTOX in later cycles. One study showed that BOTOX significantly improved symptoms from the start, suggesting it can reduce tremors. Another study found that 67% of patients experienced some improvement with BOTOX treatment. These results suggest that BOTOX could make daily tasks easier for those with UL ET by lessening tremor severity. Overall, early findings are promising for BOTOX's effectiveness in treating this condition. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults aged 18 to 80 with upper limb essential tremor (UL ET) who have been formally diagnosed by a physician can join this study. They must be willing to undergo screening and have a certain severity of tremors, but not too severe as defined by specific scales measuring tremor impact on daily activities.

Inclusion Criteria

I have been officially diagnosed with tremors by a doctor.

Do you agree to go through a test to determine how severe your tremors are?

Exclusion Criteria

I can perform most daily activities with little to no help, especially with my dominant limb.

The Essential Tremor Rating Assessment Scale (TETRAS) upper limit (UL) score (0-4 scale) > 2 in the dominant limb on at least one of the 3 maneuvers.

TREDS-Revised Scale (1-4 scale) unilateral score of >= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive BOTOX or placebo injections

12 weeks

Regular visits at a hospital or clinic

Treatment Cycle 2

Participants continue with BOTOX or placebo injections

12 weeks

Regular visits at a hospital or clinic

Treatment Cycle 3

Participants receive unilateral or bilateral BOTOX injections

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BOTOX
• Placebo for BOTOX

Trial Overview The trial is testing BOTOX injections against a placebo for treating UL ET. Participants are randomly placed into one of four groups, with a 50% chance of receiving the placebo. The treatment involves multiple cycles over approximately 36 weeks, with regular hospital or clinic visits for assessments.

How Is the Trial Designed?

Group I: Placebo/BOTOX Unilateral Experimental Treatment 2 Interventions

Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3.

Group II: Placebo/BOTOX Bilateral Experimental Treatment 2 Interventions

Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3.

Group III: BOTOX/BOTOX Unilateral Experimental Treatment 1 Intervention

Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3

Group IV: BOTOX/BOTOX Bilateral Experimental Treatment 1 Intervention

Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3

BOTOX is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Crow's Feet
• Glabellar Lines
• Facial Wrinkles
• Orbicularis Oculi
• Platysma Bands

Approved in United States as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Crow's Feet
• Glabellar Lines
• Facial Wrinkles
• Orbicularis Oculi
• Platysma Bands
• Cervical Dystonia
• Blepharospasm
• Chronic Spasticity
• Bruxism
• Dystonia
• Headache

Approved in Canada as Botox for:

• Similar to those in the United States and European Union, specific details may vary

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. news.abbvie.com news.abbvie.com/2025-10-06-AbbVie-Announces-Positive-Topline-Results-from-Phase-2-ELATE-Trial-Evaluating-OnabotulinumtoxinA-BOTOX-R-for-the-Treatment-of-Upper-Limb-Essential-Tremor

AbbVie Announces Positive Topline Results from Phase 2 ... OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2304192

Trial of Botulinum Toxin for Isolated or Essential Head Tremor The primary outcome — improvement by at least 2 points on the CGI scale at week 18 — was met by 31% of the patients in the botulinum toxin group ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12389811/

Botulinum Toxin for the Treatment of Tremors - PMC The average peak effect in the cohort was 3.0, and 35 (67%) patients reported some degree of improvement with BoNT. Transient weakness was noted ...

4. practicalneurology.com practicalneurology.com/news/study-evaluates-botox-as-essential-tremor-treatment/2483937/

Study Evaluates Botox as Essential Tremor Treatment In terms of the primary end point, there was a significant improvement in TREDS-R score at week 18, with a least squares mean change from ...

5. prnewswire.com prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-2-elate-trial-evaluating-onabotulinumtoxina-botox-for-the-treatment-of-upper-limb-essential-tremor-302575398.html

AbbVie Announces Positive Topline Results from Phase 2 ... OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline ...