Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

Study Identifier:
31-14-204
ClinicalTrials.gov Identifier:
NCT03661983
EudraCT Identifier:
2018-002270-48
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Terminated/Withdrawn
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Tourette's Disorder
Study Drug
  • Drug: Aripiprazole
  • Drug: Placebo
Date
Oct 2018 - Jun 2020
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 6 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
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

Protocol Summary

To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).

Study Locations

Location
Status
Location
Advanced Research Center
Anaheim, California, United States, 92805
Status
N/A
Location
CT Trials - Riverside
Riverside, California, United States, 92506
Status
N/A
Location
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Status
N/A
Location
Comprehensive Research Center
Norwich, Connecticut, United States, 06360
Status
N/A
Location
Sarkis Clinical
Gainesville, Florida, United States, 32607
Status
N/A
Location
Reliable Clinical Research
Hialeah, Florida, United States, 33012
Status
N/A
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July 2025 01US25EUC0279

Requirements information
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

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