- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567291
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents (ARTISTS)
November 5, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period.
This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is an otherwise open-label, single-arm study (Part A) that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3 week blinded maintenance or re-titration (Part A resumed), and then a maintenance period.
This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies (SD-809-C-17 [Phase 1b], TV50717-CNS 30046 [Phase 2/3], or TV50717-CNS 30060 [Phase 3]).
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina, C1023AAB
- Teva Investigational Site 060-1407
-
Buenos Aires, Argentina, C1425AHQ
- Teva Investigational Site 060-1402
-
La Plata, Argentina, 1900
- Teva Investigational Site 060-1403
-
Mendoza, Argentina, 5500
- Teva Investigational Site 060-1404
-
-
-
-
-
Liverpool, Australia, 2170
- Teva Investigational Site 060-1802
-
-
-
-
Ontario
-
Ajax, Ontario, Canada, L1Z0M1
- Teva Investigational Site 046-0201
-
Ottawa, Ontario, Canada, K2G 1W2
- Teva Investigational Site 046-0202
-
-
-
-
-
Bello, Colombia, 051050
- Teva Investigational Site 060-1503
-
Pereira, Colombia, 660003
- Teva Investigational Site 060-1504
-
-
-
-
-
Herlev, Denmark, 2730
- Teva Investigational Site 046-0302
-
Odense, Denmark, 5000
- Teva Investigational Site 046-0301
-
-
-
-
-
Budapest, Hungary, 1021
- Teva Investigational Site 060-0901
-
Szeged, Hungary, 6725
- Teva Investigational Site 060-0902
-
-
-
-
-
Cagliari, Italy, 09121
- Teva Investigational Site 060-1005
-
Catania, Italy, 95123
- Teva Investigational Site 060-1001
-
Naples, Italy, 80131
- Teva Investigational Site 060-1003
-
-
-
-
-
Seoul, Korea, Republic of, 110-744
- Teva Investigational Site 060-1901
-
Seoul, Korea, Republic of, 138-736
- Teva Investigational Site 060-1903
-
Seoul, Korea, Republic of, 6351
- Teva Investigational Site 060-1902
-
-
-
-
-
Culiacan, Mexico, 80020
- Teva Investigational Site 060-1601
-
Leon, Mexico, 37000
- Teva Investigational Site 060-1603
-
Monterrey, Mexico, 64460
- Teva Investigational Site 060-1602
-
Monterrey, Mexico, 64610
- Teva Investigational Site 060-1604
-
-
-
-
-
Gdansk, Poland, 80-542
- Teva Investigational Site 060-1104
-
Katowice, Poland, 40-123
- Teva Investigational Site 060-1101
-
Krakow, Poland, 31503
- Teva Investigational Site 060-1105
-
Poznan, Poland, 60-693
- Teva Investigational Site 060-1102
-
Warsaw, Poland, 02-793
- Teva Investigational Site 060-1103
-
-
-
-
-
Tomsk, Russian Federation, 634050
- Teva Investigational Site 046-0704
-
Voronezh, Russian Federation, 394024
- Teva Investigational Site 046-0703
-
-
-
-
-
Belgrade, Serbia, 11000
- Teva Investigational Site 046-1702
-
Belgrade, Serbia, 11000
- Teva Investigational Site 046-1703
-
Novi Sad, Serbia, 21000
- Teva Investigational Site 046-1701
-
-
-
-
-
Madrid, Spain, 28009
- Teva Investigational Site 046-0605
-
Madrid, Spain, 28922
- Teva Investigational Site 046-0602
-
Malaga, Spain, 29620
- Teva Investigational Site 046-0603
-
Sevilla, Spain, 41013
- Teva Investigational Site 046-0601
-
-
-
-
-
Dnipropetrovsk, Ukraine, 49101
- Teva Investigational Site 060-2003
-
Kharkiv, Ukraine, 61068
- Teva Investigational Site 060-2001
-
Kharkiv, Ukraine, 61153
- Teva Investigational Site 060-2002
-
Kiev, Ukraine, 4080
- Teva Investigational Site 060-2007
-
Kyiv, Ukraine, 4209
- Teva Investigational Site 060-2005
-
Vinnytsia, Ukraine, 21005
- Teva Investigational Site 060-2006
-
-
-
-
Alabama
-
Dothan, Alabama, United States, 36303
- Teva Investigational Site 046-0104
-
-
Arkansas
-
Rogers, Arkansas, United States, 72758
- Teva Investigational Site 046-0107
-
-
California
-
Anaheim, California, United States, 92805
- Teva Investigational Site 046-0126
-
Sacramento, California, United States, 95815
- Teva Investigational Site 046-0101
-
San Diego, California, United States, 92108
- Teva Investigational Site 046-0111
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Teva Investigational Site 060-0160
-
Gulf Breeze, Florida, United States, 32561-4458
- Teva Investigational Site 060-0166
-
Miami, Florida, United States, 33136-2107
- Teva Investigational Site 060-0161
-
Orlando, Florida, United States, 32803
- Teva Investigational Site 046-0115
-
Orlando, Florida, United States, 32819
- Teva Investigational Site 060-0153
-
Saint Petersburg, Florida, United States, 33701
- Teva Investigational Site 046-0114
-
-
Georgia
-
Atlanta, Georgia, United States, 30331
- Teva Investigational Site 046-0116
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Teva Investigational Site 060-0155
-
Chicago, Illinois, United States, 60634
- Teva Investigational Site 060-0164
-
Naperville, Illinois, United States, 60563
- Teva Investigational Site 046-0133
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Teva Investigational Site 046-0128
-
-
Missouri
-
Bridgeton, Missouri, United States, 63044
- Teva Investigational Site 060-0170
-
Saint Charles, Missouri, United States, 63304
- Teva Investigational Site 046-0110
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68526-9467
- Teva Investigational Site 046-0134
-
-
New Jersey
-
Voorhees, New Jersey, United States, 08043
- Teva Investigational Site 046-0109
-
-
New York
-
New York, New York, United States, 10029
- Teva Investigational Site 046-0124
-
New York, New York, United States, 10036
- Teva Investigational Site 060-0154
-
Rochester, New York, United States, 14618
- Teva Investigational Site 046-0102
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73116
- Teva Investigational Site 046-0106
-
-
South Carolina
-
Charleston, South Carolina, United States, 29414-5834
- Teva Investigational Site 060-0169
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-2551
- Teva Investigational Site 060-0156
-
-
Texas
-
Dallas, Texas, United States, 75243
- Teva Investigational Site 046-0113
-
Fort Worth, Texas, United States, 76104
- Teva Investigational Site 060-0163
-
Houston, Texas, United States, 77030
- Teva Investigational Site 046-0108
-
San Antonio, Texas, United States, 78249
- Teva Investigational Site 046-0120
-
-
Utah
-
Orem, Utah, United States, 84058
- Teva Investigational Site 046-0105
-
-
Virginia
-
Petersburg, Virginia, United States, 23805
- Teva Investigational Site 046-0118
-
-
Washington
-
Everett, Washington, United States, 98201-4077
- Teva Investigational Site 060-0162
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is younger than 18 years of age on day 1
- Patient weighs at least 44 pounds (20 kg)
- The patient's active tics are causing distress or impairment
- Patient is able to swallow study medication whole
- Patient is in good general health
- Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study -- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- Patient is 18 years of age or older.
- Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
- The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
- Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
- Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
- Patient has a history of suicidal intent or related behaviors within 2 years of screening
- Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
- Patient has a first-degree relative who has completed suicide.
- Patient has clinically significant obsessive-compulsive disorder (OCD) on day 1 that, in the opinion of the investigator, is the primary cause of impairment.
- Patient has received comprehensive behavioral intervention for tics for TS or cognitive behavioral therapy for OCD within 4 weeks of screening.
- Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for reduction of tics within 4 weeks of the screening visit.
- Patient has an unstable or serious medical illness at screening or day 1
- Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
- Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit.
- Patient has participated in an investigational drug or device study (with the exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060) and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever is longer.
- The patient is a pregnant or lactating female, or plans to become pregnant during the study.
- Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12 months -- Additional criteria apply, please contact the investigator for more information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEV-50717- Part A
All patients will undergo TEV-50717 dose titration in this study.
Patients will receive 6 mg of TEV-50717 with food on the evening of day 1.
The titration scheme and maximum dose will be determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.
|
6, 9, and 12 mg oral tablets
Other Names:
|
Experimental: TEV-50717- Part B RW
TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period.
|
6, 9, and 12 mg oral tablets
Other Names:
|
Placebo Comparator: Placebo- Part B RW
Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only.
|
Placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined
Time Frame: Day 1 to Week 55
|
Adverse events were analyzed for all participants in Parts A & B combined as one group for this outcome measure.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Incudes clinically significant changes such as changes in vital signs or lab values.
Relationship of AE to treatment was determined by the Investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
|
Day 1 to Week 55
|
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)
Time Frame: Weeks 28 to 30
|
Adverse events were analyzed for Part B for this outcome measure.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Incudes clinically significant changes such as changes in vital signs or lab values.
Relationship of AE to treatment was determined by the Investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
|
Weeks 28 to 30
|
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score
Time Frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time."
It contains 2 subscales (emotional problems and functional problem).
Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
|
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score
Time Frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills.
Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks.
It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems).
Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
|
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30
Time Frame: Week 28, Week 30
|
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time."
It contains 2 subscales (emotional problems and functional problem).
Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
|
Week 28, Week 30
|
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30
Time Frame: Week 28, Week 30
|
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills.
Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks.
It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems).
Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
|
Week 28, Week 30
|
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide.
Number of participants with any suicidal ideation or suicidal behavior are reported.
Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
|
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
|
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30
Time Frame: Week 28, Week 30
|
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide.
Number of participants with any suicidal ideation or suicidal behavior are reported.
Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
|
Week 28, Week 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
Time Frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics.
YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment.
Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe).
MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity.
TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe).
Higher scores indicate greater severity/worse outcome.
Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
|
Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score
Time Frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life.
The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics).
Lower scores indicate better quality of life.
Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
|
Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score
Time Frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?).
The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy.
Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
|
Baseline, Weeks 8, 15, 28, 41, 54, and 55
|
Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score
Time Frame: Baseline, Weeks 6, 28, 34, 54
|
C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms.
C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem.
Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?).
Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem).
Lower score indicated better quality of life.
Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
|
Baseline, Weeks 6, 28, 34, 54
|
Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30
Time Frame: Week 28, Week 30
|
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics.
YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment.
Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe).
MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity.
TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe).
Higher scores indicate greater severity/worse outcome.
The model is an ANCOVA model that includes fixed effects for treatment group.
The randomized withdrawal baseline TTS and age group at baseline (2 levels: 6-11 years, 12-18 years) are included as covariates.
|
Week 28, Week 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2018
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
June 12, 2018
First Submitted That Met QC Criteria
June 12, 2018
First Posted (Actual)
June 25, 2018
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
November 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- TV50717-CNS-30047
- 2016-000630-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tourette Syndrome
-
Children's Hospital Medical Center, CincinnatiTourette Association of AmericaRecruitingTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tourette Syndrome, Modifier ofUnited States
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Ministry of Health, ItalyCompletedTourette Syndrome | Tourette's Syndrome | Tourette Disorder | Gilles de la Tourette SyndromeItaly
-
Tasly Pharmaceuticals, Inc.Not yet recruitingTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Emalex Biosciences Inc.CompletedTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States, Poland, France, Canada, Germany
-
Vanderbilt University Medical CenterCompletedTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Johns Hopkins UniversityCompletedTourette Syndrome in Children | Tourette Syndrome in Adolescence | Habit Reversal Training | TicUnited States
-
Tel Aviv Medical CenterUnknownTourette Syndrome in Children | Tourette Syndrome in Adolescence | Chronic Tic DisorderIsrael
-
Wake Forest University Health SciencesUniversity of Rochester; Tourette Association of AmericaRecruitingTourette Syndrome | Tics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tic Disorder, ChildhoodUnited States
-
University of MinnesotaCompletedTourette Syndrome | Tic Disorders | Tics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tic Disorder, Childhood | Tic, MotorUnited States
-
Max Planck Institute for Human Cognitive and Brain...Hannover Medical School; Leipzig University Medical CenterCompletedTourette Syndrome | Gilles de la Tourette SyndromeGermany
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States