Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette's Syndrome

NCT02187679 | Unknown

• 1 other identifier: DCRC-ISP0016888
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 understand the right dosage of Abobotulinum toxin A which can be affective. 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. Afterward, a further evaluation of the tics will be conducted by the investigator using the Yale Global Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear, Nose and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a provoked cough by the patient. This will allow the lidocaine to be sprayed throughout the airway preventing coughing and swallowing during the procedure. An Electromyography (EMG) guidance a needle containing Dysport will be injected into the thyroarytenoid muscles will potentially reduce the vocal dyskinetic features in patients with TS. This needle will be connected to a syringe and once determined active, it will be placed appropriately when the EMG emits a characteristic sound. If this does not occur with the patient then the injection will be administered under direct vision via direct laryngoscopy using an orotracheal injector system. This procedure is conducted in an outpatient clinic because no hospitalization is required. The patient is not allowed to consume food or drink for about 45-60 minutes after the injection. The throat will be numb and may cause coughing and some blood tinged sputum: The expectancy of this outcome is reason to not consider is a serious event. Asprin and ibuprofen is not allowed a week prior to and until the injection at least 3-4 days after to prevent excessive bleeding. The patient is also instructed to ensure that they chew their food thoroughly and drink sufficient water for the initial days after the study intervention. Mild dysphasia may be noted initially which should resolve within a few hours. On Visit 1, the patient will complete all required study documents and forms. Then the ENT physician will proceed with the injection Dysport on the same day. If unforeseen circumstances render the subject unable to be injected on the same day, the intervention must take place within three days and this will be considered V1, follow up events should be scheduled accordingly.

Conditions

Tourette Syndrome; Chronic Vocal Tic

Keywords

Tourette Syndrome; Tourette's Syndrome; Chronic Vocal Tic; Vocal Tic

Outcome Measures

Primary Outcomes (1)

• Vocal Tic Reduction

  Primary Outcome will be the reduction of tics as measured by the physician after 14 days and after 30 days. Only the Yale Global Tic Severity scale will be used to the measure the number of tics and their severity throughout the course of the study. These measurements will be compared with every visit to the score prior to the intervention.

  15 days

Study Arms (1)

Abobotulinum toxin A

EXPERIMENTAL

Abobotulinum toxin A Injection

Drug: Abobotulinum toxin A

Interventions

Abobotulinum toxin A DRUG

Also known as: Dysport

Abobotulinum toxin A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Detroit Clinical Research Center: lead
• Ipsen: collaborator

Study Sites (1)

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome; Tics

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Dabrowski, MD

  Detroit Clinical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Rooker, BS

CONTACT

248-716-7009; kimberly.Rooker@dcrc.us

Christopher Clement

CONTACT

248-737-5939; chris.clement@dcrc.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)