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Neurotoxin
BOTOX Injections for Essential Tremor
Phase 2
Waitlist Available
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 belowSelect...
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
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 moreTrial 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
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.
Botulinum toxin A in non-dystonic tremors.[Medical aspects of the medical treatment in dystonia].Botulinum toxin in clinical practice.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,870 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,519 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can perform most daily activities with little to no help, especially with my dominant limb.I have been officially diagnosed with tremors by a doctor.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.Do you agree to go through a test to determine how severe your tremors are?
Research Study Groups:
This trial has the following groups:- Group 1: BOTOX/BOTOX Unilateral
- Group 2: BOTOX/BOTOX Bilateral
- Group 3: Placebo/BOTOX Unilateral
- Group 4: Placebo/BOTOX Bilateral
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Essential Tremor Patient Testimony for trial: Trial Name: NCT05216250 — Phase 2