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

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ClinicalTrials.gov Identifier: NCT03661983
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE September 13, 2018
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Time from randomization to relapse during the double-blind randomized withdrawal phase [ Time Frame: Up to 12 weeks or early termination ]
Relapse is defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase on the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03661983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder
Official Title  ICMJE 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
Brief Summary To evaluate the long-term efficacy of oral aripiprazole in pediatric subjects for the treatment of Tourette's Disorder (TD).
Detailed Description This is a phase 3b/4, randomized, double-blind, placebo-controlled, outpatient trial to evaluate the long-term efficacy of oral aripiprazole in the treatment of pediatric subjects with Tourette's Disorder (TD). The trial consists of 3 distinct phases: a pretreatment phase, open-label stabilization phase, and a double-blind randomized withdrawal phase.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subject randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety and efficacy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tourette's Disorder (TD)
Intervention  ICMJE
  • Drug: Aripiprazole (OPC-14597)
    Once daily, tablets
  • Drug: Placebo
    Once daily, tablets
Study Arms  ICMJE
  • Experimental: Aripiprazole (OPC-14597)
    2.0-20.0 mg/day; Start at 2.0 mg/day, increase to 5.0 mg after 2 days, titrate (based on 2 weight groups [<50 kg (5-10 mg/day) and >=50 kg (5-20 mg/day)]) to max of 20.0 mg/day
    Intervention: Drug: Aripiprazole (OPC-14597)
  • Placebo Comparator: Placebo
    Matching placebo, daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject 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 subject meets current 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 subject has a TTS ≥ 20 on the YGTSS at screening and baseline (Day 1).
  • The subject, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.
  • Females of childbearing potential (all female subjects ≥ 12 years of age and all female subjects < 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 subject 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 subject, 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 subject and the subject's legally acceptable representative (eg, 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 subject-reported outcomes measures, and to be reliably rated on assessment scales.

Exclusion Criteria:

  • The subject 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 subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
  • Subjects 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 subjects 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 subject currently has a primary diagnosis that meets DSM-5 criteria for mood disorder.
  • The subject has severe obsessive-compulsive disease, as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16.
  • The subject has taken aripiprazole within 1 month (30 days) of the screening visit.
  • The subject has a history of neuroleptic malignant syndrome.
  • Subject is a sexually active male or female of childbearing potential (FOCBP) (all female subjects ≥ 12 years of age and all female subjects < 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 IMP for females and males, respectively. Abstinence will be permitted if it is confirmed and documented at every trial visit.
  • The subject represents a significant risk of committing suicide based on history (suicide attempt in past 1 year).
  • The subject has a body weight < 16 kg.
  • Subjects who have taken neuroleptic or antiparkinson drugs within 14 days prior to baseline.
  • Subjects requiring cognitive-behavioral therapy (CBT) for TD during the trial period. CBT for other nonexclusionary disorder must remain consistent throught the trial.
  • The subject 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.
  • Subject 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-aceytlcysteine, 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.
  • Subject 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole Menlow +1 434.951.3506 MenlowNicole@prahs.com
Listed Location Countries  ICMJE Canada,   Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661983
Other Study ID Numbers  ICMJE 31-14-204
2018-002270-48 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eva Kohegyi, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP