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Neurotoxin

Dysport for Tourette Syndrome

N/A
Waitlist Available
Led By Edward Dabrowski, MD
Research Sponsored by Detroit Clinical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is willing and able to provide informed consent. Subjects who are younger than age 21 must have written informed consent provided by the parent or legal guardian and assent provided by the patient when appropriate.
Female subjects of childbearing age must have a negative urine pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days
Awards & highlights

Study Summary

This trial is testing the efficacy of Abobotulinum toxin A, injected into the affected vocal cords, for treating primary Tourette's syndrome. The study will involve an injection of 2.5 units of Dysport on each side of the affected vocal cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also complete a self assessment survey on how vocal tics affect their daily lives.

Who is the study for?
This trial is for adults aged 18-65 with Primary Tourette's Syndrome or chronic Tic Disorder, having tics for over a year. Participants need a specific score on the Yale Global Tic Severity Scale and up-to-date tetanus shots. Women of childbearing age must test negative for pregnancy. Excluded are those with certain mental health issues, substance dependence, autoimmune diseases, allergies to Dysport, STDs like HIV/Herpes/Gonorrhea, previous BoNT treatment failures or side effects.Check my eligibility
What is being tested?
The study tests the effectiveness of Abobotulinum toxin A (Dysport) injections into vocal cords to treat vocal tics in Tourette's Syndrome patients. Dosage determination and impact on daily life are assessed through self-surveys and YGTSS evaluations by an ENT physician using EMG guidance during outpatient visits.See study design
What are the potential side effects?
Possible side effects include throat numbness leading to coughing and blood-tinged sputum which isn't considered serious. Aspirin and ibuprofen are prohibited around injection time due to bleeding risks. Mild dysphagia (difficulty swallowing) may occur initially but should resolve within hours.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to agree to participate in the study, or if under 21, my guardian has consented and I agree.
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I am of childbearing age and my pregnancy test is negative.
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I am between 18 and 65 years old and have been diagnosed with Tourette Syndrome or chronic Tic Disorder for over a year.
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I can and will give my consent, or if under 21, my guardian will.
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I am between 18 and 65 years old and have been diagnosed with Tourette Syndrome or chronic Tic Disorder for over a year.
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I am of childbearing age and my pregnancy test is negative.
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My tetanus shots are current.
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My tetanus shots are current.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vocal Tic Reduction

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abobotulinum toxin AExperimental Treatment1 Intervention
Abobotulinum toxin A Injection

Find a Location

Who is running the clinical trial?

Detroit Clinical Research CenterLead Sponsor
IpsenIndustry Sponsor
344 Previous Clinical Trials
73,009 Total Patients Enrolled
Edward Dabrowski, MDPrincipal InvestigatorDetroit Clinical Research Center

Media Library

Abobotulinum toxin A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT02187679 — N/A
Tourette Syndrome Research Study Groups: Abobotulinum toxin A
Tourette Syndrome Clinical Trial 2023: Abobotulinum toxin A Highlights & Side Effects. Trial Name: NCT02187679 — N/A
Abobotulinum toxin A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02187679 — N/A

Frequently Asked Questions

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

To what end is Abobotulinum toxin A typically administered?

"Abobotulinum toxin A is a proven remedy for urinary incontinence, spinal cord issues, and even botox treatments."

Answered by AI

Is the patient eligibility cut-off for this experiment 85 years of age or lower?

"The parameters for enrolment in this trial involve patients who are between 18 and 65 years of age. For those younger than 18, there are 390 studies available, while 1048 can be found if the patient is over 65."

Answered by AI

Has Abobotulinum toxin A been tested in other scientific investigations?

"Currently, there are 61 Abobotulinum toxin A studies in progress with 20 of those trials being Phase 3. The majority are located in Farmington Hills, Michigan; however, this medication is also tested at 759 different sites around the world."

Answered by AI

What is the upper limit for participants in this research endeavor?

"Unfortunately, this clinical trial is closed to new participants. Its initial posting date was January 1st 2014 with its final update on February 9th 2015. Nonetheless, if you are looking for other studies related tourette syndrome 1409 studies and 61 trials featuring Abobotulinum toxin A presently exist that are actively recruiting patients."

Answered by AI

Is enrollment still available for this clinical experiment?

"The trial's page on clinicaltrials.gov indicates that recruitment has ceased, as this medical study was first posted in January 2014 and last updated nearly a year later. Yet, there are 1,470 other studies still actively recruiting patients right now."

Answered by AI

Are there any conditions to qualify for participation in this research project?

"This clinical trial is seeking 30 individuals with a diagnosis of Tourette syndrome (TS) or Chronic Tic Disorder, who are between the ages 18 and 65. All participants should be up-to-date on their tetanus immunization, receive informed consent from either themselves if older than 21 years old or their legal guardian/parent otherwise; they must have a Yale Global Tic Severity Scale score ≥20 for TS or ≥14 for chronic tics disorder, as well as provide evidence of not being pregnant via negative urine pregnancy test."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Mar 2025