What side effects are associated with this type of intervention?

Common side effects of botulinum toxin injections for Essential Tremor include transient focal weakness, pain at the injection site, dry mouth, and musculoskeletal pain. These side effects are typically mild to moderate and temporary. There is also a risk of more serious adverse effects, such as difficulty swallowing or breathing, if the toxin spreads beyond the targeted area.

What prior FDA approvals exist?

Botulinum toxin injections, such as BOTOX, have been studied and used for the treatment of Essential Tremor (ET). These injections work by blocking the release of acetylcholine at the neuromuscular junction, thereby reducing muscle contractions and tremors. While BOTOX is being investigated specifically for upper limb essential tremor, it has shown promise in reducing tremor severity and improving function in affected individuals. Other treatments for ET include medications like propranolol and primidone, but these do not work through the same mechanism as botulinum toxin.

What other types of research exist?

Promising novel alternatives to BOTOX for Essential Tremor patients include focused ultrasound thalamotomy, which uses MRI-guided ultrasound waves to target and destroy tremor-causing brain tissue, and transcranial magnetic stimulation (TMS), a non-invasive technique that modulates neural activity. Additionally, advancements in deep brain stimulation (DBS) with adaptive algorithms that adjust stimulation in real-time based on tremor severity are also being explored.

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Neurotoxin

BOTOX Injections for Essential Tremor

Phase 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a physician given you a formal diagnosis of tremors?

Are you willing to screening to confirm the severity of your tremors?

Must not have

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 3 weeks

Treatment Varies

Follow Up week 24

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not explicitly listed in the provided information, typical side effects from BOTOX may include pain at the injection site, muscle weakness near where the medicine was injected, bruising or bleeding where BOTOX was injected, headache, fever and chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been officially diagnosed with tremors by a doctor.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items

Secondary study objectives

Change From Baseline in Clinical Global Impression of Severity (CGI-S)

Change From Baseline in Essential Tremor Rating Assessment (TETRAS UL) Score

Change From Baseline in Patient Global Impression of Severity (PGI-S)

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Placebo/BOTOX UnilateralExperimental Treatment2 Interventions

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

Group II: Placebo/BOTOX BilateralExperimental Treatment2 Interventions

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

Group III: BOTOX/BOTOX UnilateralExperimental Treatment1 Intervention

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

Group IV: BOTOX/BOTOX BilateralExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1410

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Essential Tremor (ET) include BOTOX injections, neuromodulation, and biomechanical loading. BOTOX works by blocking the release of acetylcholine at the neuromuscular junction, thereby reducing muscle contractions and tremors. Neuromodulation involves noninvasive nerve stimulation to improve motor control, while biomechanical loading applies external forces or facilitates antagonist muscle contractions to stabilize tremulous limbs. These mechanisms are crucial for ET patients as they directly target the muscle activity and neural pathways responsible for tremors, offering potential relief from the debilitating effects of the condition.

Botulinum toxin A in non-dystonic tremors.[Medical aspects of the medical treatment in dystonia].Botulinum toxin in clinical practice.