Tourette's Disorder (TD) Clinical Trial
Official title:
A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder
| Verified date | February 2021 |
| Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
| Status | Terminated |
| Enrollment | 36 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility | Inclusion Criteria: - The participant is a male or female child or adolescent, 6 to 17 years of age (inclusive) at the time of signing the informed consent/assent. - The participant meets current Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for TD, documented at screening and made by an adequately trained clinician, as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version. - The participant has a Total Tic Score (TTS) = 20 on the Yale Global Tic Severity Scale (YGTSS) at screening and baseline (Day 1). - The participant, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the participant's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships. - Females of childbearing potential (all female participants = 12 years of age and all female participants < 12 years of age if menstruation has started) must have a negative pregnancy test and must not be pregnant or lactating. - Written informed consent must be obtained from the participant or a legally acceptable representative (eg, guardian or caregiver), in accordance with requirements of the trial site's institutional review board (IRB)/independent ethics committee (IEC) and local regulatory requirements, prior to the initiation of any protocol-required procedures. In addition, the participant, as required by the trial center's IRB/IEC, must provide informed assent at screening and as such must be able to understand that he or she can withdraw from the trial at any time. - Ability, in the opinion of the principal investigator, of the participant and the participant's legally acceptable representative (e.g., guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications, to read and understand the written word in order to complete participant-reported outcomes measures, and to be reliably rated on assessment scales. Exclusion Criteria: - The participant presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements. These include, but are not limited to, the following: Transient tic disorder; Huntington's disease; Parkinson's disease; Sydenham's chorea; Wilson's disease; Mental retardation; Pervasive developmental disorder; Tardive dyskinesia; Traumatic brain injury; Stroke; Restless legs syndrome. - The participant has a history of schizophrenia, bipolar disorder, or other psychotic disorder. - Participants who receive psychostimulants for the treatment of attention-deficit hyperactivity disorder (ADHD) and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment. (Note that participants with ADHD who are treated with psychostimulants and have not developed new tics or a worsening of their current tics can be included if all other enrollment obligations are met). - The participant currently has a primary diagnosis that meets DSM-5 criteria for mood disorder. - The participant has severe obsessive-compulsive disease, as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16. - The participant has taken aripiprazole within 1 month (30 days) of the screening visit. - The participant has a history of neuroleptic malignant syndrome. - Participant is a sexually active male or female of childbearing potential (FOCBP) (all female participants = 12 years of age and all female participants < 12 years of age if menstruation has started) who will not agree to practice 2 acceptable methods of birth control or who will not remain abstinent during the trial and for 30 or 90 days following the last dose of Investigational medicinal product (IMP) for females and males, respectively. Abstinence will be permitted if it is confirmed and documented at every trial visit. - The participant represents a significant risk of committing suicide based on history (suicide attempt in past 1 year). - The participant has a body weight < 16 kg. - Participants who have taken neuroleptic or antiparkinson drugs within 14 days prior to baseline. - Participants requiring cognitive-behavioral therapy (CBT) for TD during the trial period. CBT for other nonexclusionary disorder must remain consistent through the trial. - The participant has met DSM-5 criteria for any significant psychoactive substance use disorder within the past 3 months. - A positive drug screen for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADHD). Investigators can choose to repeat a positive drug screen one time during screening period after concurrence from the medical monitor. A second positive test for any drug of abuse would be exclusionary. - Participant requiring medication not allowed per protocol. - Use of any cytochrome P450 (CYP)2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to baseline and for the duration of the trial. - Other nutritional or dietary supplements and nonprescription herbal preparations for TD (eg, cannabinoids, N-acetylcysteine, omega-3 fatty acids, kava extracts, GABA supplements) within 7 days prior to baseline and for the duration of the trial, unless approved in advance by the medical monitor. - The inability to swallow tablets or tolerate oral medication. - Participant has participated in a clinical trial involving either study medication or interventional (non-medication) treatment for TD within the last 60 days. - The following laboratory test results, vital signs and electrocardiogram (ECG) results are exclusionary: Platelets = 75,000/mm^3; Hemoglobin = 9 g/dL; Neutrophils, absolute = 1000/mm^3; Aspartate aminotransferase > 3 × upper limit of normal (ULN) as defined by the central laboratory; Alanine aminotransferase > 3 × ULN as defined by the central laboratory; Creatinine = 2 mg/dL; Diastolic blood pressure > 105 mmHg; Corrected QT interval = 450 msec (males) or = 470 msec (females) using the corrected QT interval for heart rate using Fridericia's formula |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Kids Clinic | Ajax | Ontario |
| Canada | Jodha Tishon Inc. | Toronto | Ontario |
| Hungary | Semmelweis Egyetem - I. sz. Gyermekgyógyászati Klinika | Budapest | |
| Hungary | Vadaskert Alaptvany A Gyermekek Lelki Egeszsegeert | Budapest | |
| United States | Advanced Research Center | Anaheim | California |
| United States | Pediatric and Adolescent Neurodevelopment Associates | Atlanta | Georgia |
| United States | BioBehavioral Research of Austin | Austin | Texas |
| United States | Quest Therapeutics of Avon Lake DBA Haidar Almhana Nieding | Avon Lake | Ohio |
| United States | Neurobehavioral Medicine Group | Bloomfield Hills | Michigan |
| United States | New Hope Clinical Research | Charlotte | North Carolina |
| United States | University of Virginia School of Medicine | Charlottesville | Virginia |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | Triangle Neuropsychiatry | Durham | North Carolina |
| United States | Core Clinical Research | Everett | Washington |
| United States | Inova Clinical trials and Research Center | Fayetteville | Georgia |
| United States | Sarkis Clinical | Gainesville | Florida |
| United States | Charak Center for Health and Wellness | Garfield Heights | Ohio |
| United States | Eastern Research | Hialeah | Florida |
| United States | Reliable Clinical Research | Hialeah | Florida |
| United States | University Hills Clinical Research | Irving | Texas |
| United States | Alivation | Lincoln | Nebraska |
| United States | North Star Medical Research | Middleburg Heights | Ohio |
| United States | The NeuroCognitive Institute | Mount Arlington | New Jersey |
| United States | Baber Research Group | Naperville | Illinois |
| United States | Manhattan Behavioral Medicine | New York | New York |
| United States | Mood Disorders Consulting Medicine | New York | New York |
| United States | Comprehensive Research Center | Norwich | Connecticut |
| United States | ClinMed Research Associates, Inc. | Oklahoma City | Oklahoma |
| United States | IPS Research | Oklahoma City | Oklahoma |
| United States | Rivus Wellness and Research Institute | Oklahoma City | Oklahoma |
| United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
| United States | Aspen Clinical Research - Orem | Orem | Utah |
| United States | Clinical Research Partners - Richmond | Petersburg | Virginia |
| United States | Psychiatric Medical Associates | Plano | Texas |
| United States | CT Trials - Riverside | Riverside | California |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | Rothman Center for Pediatric Neuropsychiatry | Saint Petersburg | Florida |
| United States | Clinical Trials of Texas | San Antonio | Texas |
| United States | Syrentis Clinical Research | Santa Ana | California |
| United States | Quest Pharmaceutical Services - Miami Research Associates | South Miami | Florida |
| United States | Palouse Psychiatry & Behavioral Health | Spokane | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States, Canada, Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase | Relapse was defined as a loss of = 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. | From Randomization up to 12 weeks in Double-blind Randomized Withdrawal Phase |