BOTOX Injections for Essential Tremor

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

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if BOTOX can help reduce arm shaking in adults with essential tremor. Participants will receive BOTOX injections over several cycles. The study will check for safety and effectiveness through medical assessments and questionnaires. Botulinum toxin type A (BOTOX) has been found effective in treating various movement disorders, including essential tremor, in previous studies.

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.

What data supports the effectiveness of the drug BOTOX for treating essential tremor?

Research shows that BOTOX (botulinum toxin A) can help reduce tremors in some patients with essential tremor, although it may cause muscle weakness. In one study, 38% of patients reported moderate to marked improvement in their tremors after BOTOX injections. ^{1 2 3 4 5}

Is BOTOX safe for treating essential tremor?

BOTOX injections for essential tremor can cause side effects like hand weakness in many patients, but these effects are usually mild and temporary. In studies, some patients reported improvements in their condition, but the treatment's safety profile is generally considered acceptable for use in humans. ^{1 2 3 6 7}

How does the drug BOTOX differ from other treatments for essential tremor?

BOTOX (onabotulinumtoxinA) injections for essential tremor are unique because they target specific muscles to reduce tremor, but they can cause hand weakness in some patients, which limits their use. This approach is different from oral medications, as it involves direct muscle injections and may provide subjective improvement even if objective measures show limited change. ^{1 2 3 6 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Botulinum Toxin in Parkinson Disease Tremor: A Randomized, Double-Blind, Placebo-Controlled Study With a Customized Injection Approach. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin in essential hand tremor - A randomized double-blind placebo-controlled study with customized injection approach. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin A injections for the treatment of hand tremors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term tremor therapy for Parkinson and essential tremor with sensor-guided botulinum toxin type A injections. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum toxin A in non-dystonic tremors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin treatment of essential head tremor. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Treatment with Botulinum Neurotoxin Improves Activities of Daily Living and Quality of Life in Patients with Upper Limb Tremor. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin for essential tremor of the voice with multiple anatomical sites of tremor: a crossover design study of unilateral versus bilateral injection. [2010]