Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome

NCT03487783 | Completed Phase 3

• 1 other identifier: 031-403-00107
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the safety, efficacy, tolerability and steady-state plasma trough concentration of flexible-dosed aripiprazole once-daily administration in children and adolescents with Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2\~20 mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8 weeks.

Conditions

Tourette Syndrome

Keywords

Tourette; Aripiprazole Oral Solution

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline to Week 8 (or endpoint) in YGTSS TTS.

  The objective of the primary analysis is to compare the efficacy of flexible-dosed aripiprazole oral solution (2\~20 mg/day) with placebo in the suppression of tics in children and adolescents with a diagnosis of Tourette's syndrome. The efficacy is assessed by the changes of total tic scores (TTS) from randomization to the last visit (Week 8) on the Yale Global Tic Severity Scale (YGTSS).

  Baseline and 8 weeks (or endpoint)

Secondary Outcomes (4)

• Percentage change from Baseline to Week 8 (or endpoint) in YGTSS TTS;

  Baseline and 8 weeks (or endpoint)

• Response rate on TS-CGI Improvement scale

  Baseline and 8 weeks (or endpoint)

• Partial remission rate on TS-CGI Improvement scale

  Baseline and 8 weeks (or endpoint)

• Changes from Baseline to Week 8 (or endpoint) in TS-CGI Severity scale scores

  Baseline and 8 weeks (or endpoint)

Study Arms (2)

Aripiprazole Oral Solution

EXPERIMENTAL

1 mg/mL, 2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal

Drug: Aripiprazole Oral Solution

Placebo Oral Solution

PLACEBO COMPARATOR

2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal

Drug: Placebo Oral Solution

Interventions

Aripiprazole Oral Solution DRUG

Aripiprazole 2-20 mg/day (2-20 mL/day)

Also known as: Aripiprazole OS, Abilify

Aripiprazole Oral Solution

Placebo Oral Solution DRUG

Placebo 2-20 mg/day (2-20 mL/day)

Also known as: Placebo

Placebo Oral Solution

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent form must be obtained from a legal guardian (and the subject)
• The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
• The subject is a male or female child or adolescent, 6-18 years of age (6≤ Age \<18) at the time of Baseline Visit (V2);
• The subject meets the current DSM-IV-TR diagnostic criteria for Tourette's syndrome and requires drug therapy;
• The subject has a TTS ≥ 22 on the YGTSS at Baseline Visit (V2);

You may not qualify if:

• Women of childbearing potential (WOCBP) who will not commit to utilizing the approved birth control methods or who will not remain abstinent during the trial and for 8 weeks following the final dose of study drug; Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 mIU/mL\].
• Females who have a positive pregnancy test result or who are pregnant or breast-feeding;
• Subjects who have secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism;
• Subjects who have comorbidities requiring drug therapy, such as attention deficit / attention-deficit hyperactivity, obsessive-compulsive disorder, or oppositional defiant disorder (if a case is judged by the investigator that drug therapy is not required for any of the above diseases during this study, then the patient is eligible to participate in this trial);
• Subjects who have lower intelligence;
• Subjects who have a current diagnosis of bipolar disorder, mental disorder, schizophrenia, or depressive disorder;
• Subjects who have records of neuroleptic malignant syndrome;
• Subjects who have experienced episodes of epileptic seizure in the past year;
• Subjects who have a history of severe traumatic brain injury or stroke;
• Subjects who have any unstable medical conditions or are currently ill (e.g., congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, or will interfere with safety and efficacy assessments
• Subjects who require both drug therapy and cognitive-behavioral therapy (CBT, including habitual inversion therapy, cognitive therapy, relaxation training, etc.) during the trial period;
• Patients with the following laboratory test results, vital signs, measurements, and electrocardiogram (ECG) results will be excluded:
• QTc \> 450 msec (male), QTc \> 470 msec (female)
• Platelets (\< lower limit)
• Hemoglobin (\< lower limit)

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

• He F, Luo J, Huang Y, Hao Y, Sun L, Ke X, Wu B, Chen Y, Han Y, Zhang Y, Liu J, Han H, Xian M, Uki M, Zheng Y. Randomized, double-blind, placebo-controlled trial of aripiprazole oral solution in children and adolescents with Tourette's disorder. Child Adolesc Psychiatry Ment Health. 2024 Jul 18;18(1):88. doi: 10.1186/s13034-024-00764-6.

  PMID: 39026306 DERIVED

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Patyman Juma

  Otsuka Beijing Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 4, 2018
• Study Start: May 2, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)