Status:
UNKNOWN
Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette's Syndrome
Lead Sponsor:
Detroit Clinical Research Center
Collaborating Sponsors:
Ipsen
Conditions:
Tourette Syndrome
Chronic Vocal Tic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy trial to understan...
Detailed Description
The intervention for this pilot study will be the injection of Dysport (Abobotulinum toxin A) into the affected vocal cords for all patients with the diagnosis of Primary Tourette's syndrome. A total ...
Eligibility Criteria
Inclusion
- Male or Female subjects between the ages of 18 and 65 with a primary clinical diagnosis of TS or chronic Tic Disorder with a duration of tics greater than one year.
- 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.
- Up to date tetanus immunization.
- Yale Global Tic Severity Scale score ≥20 with TS diagnosis or ≥14 for a Chronic Tic disorder.
- Female subjects of childbearing age must have a negative urine pregnancy test.
Exclusion
- Patients who have a diagnosis of substance dependence disorder.
- Patients diagnosed with a significant and unstable major psychiatric disorder requiring treatment such as: Schizophrenia or Bipolar Disorder. Comorbid conditions such as: Obsessive Compulsive Disorder (OCD) and Attention Deficit Hyperactivity Disorder (ADHD) can be included.
- Patients diagnosed with the following types of Obsessive Compulsive Disorders: (All other types of obsessive compulsive disorders are acceptable)
- Obsessive Compulsive Disorder for hand washing
- Obsessive Compulsive Disorder for finger biting
- Obsessive Compulsive Disorder for eye poking
- Obsessive Compulsive Disorder for Dermatolomania
- Obsessive Compulsive Disorder for Trichotillomania
- Obsessive Compulsive Disorder for Head-Banging
- Patients with mental retardation.
- Patients diagnosed with progressive or degenerative neurological disorders or a structural disorder of the brain from birth, trauma or past infection.
- Patients taking more than one agent for the treatment of tics, more than one agent for the treatment of comorbid symptoms or more than one agent for the treatment of ADHD and/or the dose of the current treatment has not been stable for a minimum of 6 weeks.
- Female subjects who are pregnant or lactating.
- Allergy or hypersensitivity to Dysport or any other BoNT agent or their excipients
- Contraindications to treatment with any BoNT-A or BoNT-B preparations
- Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse event
- Anticipated concomitant treatment with BoNT for other than TS
- Patients with sexually transmitted diseases such as: HIV, Herpes, Gonorrhea amongst others.
- Continuing Medications such as cholinergic medications.
- Autoimmune diseases like Myasthenia Gravis
- Unable or unwilling to maintain abstinence or use contraception for 28 days following all Dysport injections.
- Some forms of Cognitive impairment
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02187679
Start Date
January 1 2014
Last Update
February 10 2015
Active Locations (1)
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1
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334