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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
Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of BOTOX for the treatment of UL ET.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items
Secondary outcome measures
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
~1200

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,216 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,935 Total Patients Enrolled

Media Library

BOTOX (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05216250 — Phase 2
Essential Tremor Research Study Groups: BOTOX/BOTOX Unilateral, BOTOX/BOTOX Bilateral, Placebo/BOTOX Unilateral, Placebo/BOTOX Bilateral
Essential Tremor Clinical Trial 2023: BOTOX Highlights & Side Effects. Trial Name: NCT05216250 — Phase 2
BOTOX (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05216250 — Phase 2
Essential Tremor Patient Testimony for trial: Trial Name: NCT05216250 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"As indicated by clinicaltrials.gov, this medical experiment is actively welcoming participants. The trial began recruiting on April 12th 2022 and the latest update was posted on November 9th of that same year."

Answered by AI

To what demographic is this medical research open?

"For this research initiative, 174 individuals suffering from familial tremors between 18 and 80 years of age are sought. To qualify, applicants should have acquired a formal diagnosis by their physician and be willing to undergo screening to determine the gravity of their condition."

Answered by AI

Are geriatric patients permissible for this investigation?

"All individuals that are of legal age or above and below 80 years old may apply to this trial."

Answered by AI

In what geographic areas is this experimental protocol being implemented?

"This study is being offered in 47 locations, including Accellacare Winston-Salem in Winston-Salem, Texas Neurology /ID# 250428 in Dallas, and The Orthopedic Foundation /ID# 232234 located in New Albany."

Answered by AI

What potential risks or side effects are associated with BOTOX treatments?

"Our team's assessment of BOTOX safety landed at a 2 out of 3, as Phase 2 trials only provide evidence to suggest its safety rather than any efficacy."

Answered by AI

What is the scope of participation in this medical research?

"Affirmative. Clinicaltrials.gov exhibits that this research trial, which was initially posted on April 12th 2022, is currently seeking for participants. An estimated 174 individuals must be found from 47 distinct centres of care."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Missouri
Other
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
Kansas Institute of Research /ID# 231623
Other
Accellacare Winston-Salem
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
1

Why did patients apply to this trial?

Wanting to explore options. It would change my life if there was a way to reduce the tremors.
PatientReceived 1 prior treatment
I have tried proponalol and primidone doses but it can't improve my condition so I hope that this test improve my health.
PatientReceived 2+ prior treatments
I’ve tried Propranolol and primedone. Both had unacceptable side effects. I work in a lab at tasks that require manual dexterity. They are becoming increasingly more difficult to perform.
PatientReceived 2+ prior treatments
I have tried multiple drugs, but was unable to continue them due to side effects. I have had to change specialty in my career (RN) due to my tremor. I am interested in this clinical trial as it does not include brain surgery!
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
2022. "Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216250.
All > Essential Tremor
~50 spots leftby Mar 2025
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