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

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Brief Title

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

Official Title

A Multicenter, Randomized, Double-Blind, Flexible-Dosed, Placebo-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Tourette's Syndrome

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.
    

Detailed Description

      Screening phase: It can last up to 42 days, including the screening visit (V1), a washout
      period when applicable, additional screening visit (V1a) and baseline visit (V2). The
      screening phase will serve the following purposes: 1) To allow for appropriate washout of
      prohibited medications; 2) To review the screening data; 3) To establish a pretreatment
      baseline of critical outcome measures.

      Treatment phase: It lasts 8 weeks; the purpose of the treatment phase is to assess the
      efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole
      in the treatment of children and adolescents with Tourette's syndrome.

      Safety follow-up phase: All subjects will be followed up for safety (adverse events) at Day
      16 after the final medication via telephone
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Tourette Syndrome

Intervention

Aripiprazole Oral Solution

Study Arms / Comparison Groups

 Aripiprazole Oral Solution
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

121

Start Date

May 2, 2018

Completion Date

February 14, 2020

Primary Completion Date

February 14, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent form must be obtained from a legal guardian (and the subject)

          2. 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.

          3. 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);

          4. The subject meets the current DSM-IV-TR diagnostic criteria for Tourette's syndrome
             and requires drug therapy;

          5. The subject has a TTS ≥ 22 on the YGTSS at Baseline Visit (V2);

        Exclusion Criteria:

          1. 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].

          2. Females who have a positive pregnancy test result or who are pregnant or
             breast-feeding;

          3. Subjects who have secondary tic symptoms accompanied by late-onset tics, Huntington's
             chorea, neuroacanthocytosis, mental retardation, or autism;

          4. 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);

          5. Subjects who have lower intelligence;

          6. Subjects who have a current diagnosis of bipolar disorder, mental disorder,
             schizophrenia, or depressive disorder;

          7. Subjects who have records of neuroleptic malignant syndrome;

          8. Subjects who have experienced episodes of epileptic seizure in the past year;

          9. Subjects who have a history of severe traumatic brain injury or stroke;

         10. 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

         11. Subjects who require both drug therapy and cognitive-behavioral therapy (CBT,
             including habitual inversion therapy, cognitive therapy, relaxation training, etc.)
             during the trial period;

         12. 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)

               -  Neutrophils (< lower limit)

               -  AST (SGOT) or ALT (SGPT) (> upper limit)

               -  Creatinine (> upper limit) Subjects should be excluded if they have any other
                  abnormal laboratory tests, vital sign results, or ECG findings which in the
                  investigator's judgment is medically significant and will impact the safety of
                  the subject or the interpretation of the trial results;

         13. Subjects who have a body weight of lower than 15 kg;

         14. Subjects who have been known to be with allergy or hypersensitivity to aripiprazole or
             other dihydroquinolones (e.g., carteolol, vesnarinone and cilostazol);

         15. Subjects who have participated in any clinical trial of any drugs within the past one
             month;

         16. Subjects who may require concomitant treatments prohibited as per the protocol during
             the trial period (referring to Section 7 Prohibited and Restricted Therapies);

         17. Subjects who were previously enrolled in clinical trials of aripiprazole (excluding
             investigator-sponsored trials);

         18. Subjects who are considered to have developed resistance to antipsychotic drugs by the
             investigator due to lack of efficacy after receiving 2 different antipsychotic drugs
             at reasonable doses and at least 3 weeks of treatment with each respectively;

         19. Subjects who are considered to have developed resistance to aripiprazole by the
             investigator due to lack of efficacy after an adequate time of treatment with adequate
             dose;
      

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Patyman Juma, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03487783

Organization ID

031-403-00107


Responsible Party

Sponsor

Study Sponsor

Otsuka Beijing Research Institute


Study Sponsor

Patyman Juma, Study Director, Otsuka Beijing Research Institute


Verification Date

January 2020