Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661983
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Tourette's Disorder (TD) Drug: Aripiprazole (OPC-14597) Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
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
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
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Aripiprazole (OPC-14597)
Once daily, tablets

Placebo Comparator: Placebo
Matching placebo, daily
Drug: Placebo
Once daily, tablets




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661983


Contacts
Layout table for location contacts
Contact: Nicole Menlow +1 434.951.3506 MenlowNicole@prahs.com

  Show 31 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Layout table for investigator information
Study Director: Eva Kohegyi, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.

Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03661983     History of Changes
Other Study ID Numbers: 31-14-204
2018-002270-48 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Aripiprazole
Tourette's Disorder
Pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Aripiprazole
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists