Tourette SyndromeNCT02187679
Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette's Syndrome
A study testing Abobotulinum toxin A in people with Tourette Syndrome and Chronic Vocal Tic, run by Detroit Clinical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette Syndrome, Chronic Vocal Tic
- What is being tested?
- Abobotulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Candice Shallal, BS, 248-716-7009 ext. 190, candice.shallal@dcrc.us
Edward Dabrowski, MD
About this study
Official title: An Open Label, One Arm Pilot Study to Measure the Efficacy and Safety of Dysport in the Treatment of Vocal Tics in Patients With Tourette's Syndrome and Chronic Tic Disorders
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.
Read the 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 of 5 units of Dysport (on each side) will be administered to patients diagnosed with TS to determine whether they exhibit a reduction in the number of vocal tics. The patients will complete a self assessment survey about the manner in which the vocal tics are affecting their daily lives. Further evaluation of the tics will be conducted by the investigator using the Yale Global Tic Severity Scale (YGTSS) evaluation.
The intervention will be completed by a licensed ENT (Ears Nose and Throat) physician. The procedure will be conducted in an outpatient clinic setting because no hospitalization is required for this study. The windpipe will be numbed by a 2% lidocaine followed by a provoked cough by the patient. This will enable the lidocaine to be sprayed throughout the airway preventing any coughs or swallowing during the main intervention procedure. Under Electromyography (EMG) guidance a needle containing Dysport will be injected into the thyroarytenoid muscles which will potentially reduce the vocal dyskinetic features in individuals with TS. The needle containing Dysport will be connected to a syringe and once it is determined it is active, it will be placed appropriately when the EMG emits a characteristic sound. A total of 5 units of Dysport (2.5 units on each side) will be administered to the patient. 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.
The patient will not be allowed to consume food or drink for approximately 45-60 minutes after Dysport has been injected. The throat will be numb after the anesthetic and may cause coughing and some blood tinged sputum which is expected and hence will not be considered a serious event. The patient will not be allowed to consume aspirin or ibuprofen a week prior to and till the intervention for at least 3-4 days after the intervention to prevent excessive bleeding. The patient will also be provided with specific instructions 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 (Day 1), after the patient has completed all the required study documents and forms, the ENT physician will proceed with the injection of Dysport on the same day. However, if due to unforeseen circumstances, the subject cannot be injected on the same day, the intervention must take place within three days and this will be considered V1 (Day 1) and all follow up visits should be scheduled accordingly.
- Conditions
- Tourette Syndrome, Chronic Vocal Tic
- Being tested
- Abobotulinum toxin A
- Keywords
- Tourette Syndrome, Tourette's Syndrome, Chronic Vocal Tic, Vocal Tic
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abobotulinum toxin ADrug
Also called Dysport
| Study group | Role | What they receive |
|---|---|---|
| Abobotulinum toxin A | Experimental | Abobotulinum toxin A Injection Receives: Drug: Abobotulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Detroit Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Edward Dabrowski, MD, Principal investigator, Detroit Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187679
- Sponsor's protocol ID
- DCRC-ISP0016888
- Status last verified
- Feb 2015
- First submitted
- 9 Jul 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, One Arm Pilot Study to Measure the Efficacy and Safety of Dysport in the Treatment of Vocal Tics in Patients With Tourette's Syndrome and Chronic Tic Disorders
- ClinicalTrials.gov ID
- NCT02187679
- Acronym / sponsor ID
- DCRC-ISP0016888
- Conditions
- Tourette Syndrome, Chronic Vocal Tic
- Keywords
- Tourette Syndrome, Tourette's Syndrome, Chronic Vocal Tic, Vocal Tic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Detroit Clinical Research CenterUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 of 5 units of Dysport (on each side) will be administered to patients diagnosed with TS to determine whether they exhibit a reduction in the number of vocal tics. The patients will complete a self assessment survey about the manner in which the vocal tics are affecting their daily lives. Further evaluation of the tics will be conducted by the investigator using the Yale Global Tic Severity Scale (YGTSS) evaluation.
The intervention will be completed by a licensed ENT (Ears Nose and Throat) physician. The procedure will be conducted in an outpatient clinic setting because no hospitalization is required for this study. The windpipe will be numbed by a 2% lidocaine followed by a provoked cough by the patient. This will enable the lidocaine to be sprayed throughout the airway preventing any coughs or swallowing during the main intervention procedure. Under Electromyography (EMG) guidance a needle containing Dysport will be injected into the thyroarytenoid muscles which will potentially reduce the vocal dyskinetic features in individuals with TS. The needle containing Dysport will be connected to a syringe and once it is determined it is active, it will be placed appropriately when the EMG emits a characteristic sound. A total of 5 units of Dysport (2.5 units on each side) will be administered to the patient. 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.
The patient will not be allowed to consume food or drink for approximately 45-60 minutes after Dysport has been injected. The throat will be numb after the anesthetic and may cause coughing and some blood tinged sputum which is expected and hence will not be considered a serious event. The patient will not be allowed to consume aspirin or ibuprofen a week prior to and till the intervention for at least 3-4 days after the intervention to prevent excessive bleeding. The patient will also be provided with specific instructions 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 (Day 1), after the patient has completed all the required study documents and forms, the ENT physician will proceed with the injection of Dysport on the same day. However, if due to unforeseen circumstances, the subject cannot be injected on the same day, the intervention must take place within three days and this will be considered V1 (Day 1) and all follow up visits should be scheduled accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abobotulinum toxin A | Experimental | Drug: Abobotulinum toxin AAbobotulinum toxin A Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abobotulinum toxin AAlso: Dysport | Drug | Abobotulinum toxin A |
Primary outcome
Vocal Tic Reduction
Time frame: 15 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Dabrowski, MD principal investigator
Detroit Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abobotulinum toxin A in people with Tourette Syndrome and Chronic Vocal Tic, run by Detroit Clinical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Rooker, BS (248-716-7009 ext. 191, kimberly.Rooker@dcrc.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal Tic Reduction (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.