Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Tourette's Disorder

Treatments: Drug: Placebo; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01418352

31-10-273

Details and patient eligibility

About

The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Enrollment: 83 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5
• Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline
• 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 must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception, and must not be pregnant or lactating.
• Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Screening as applicable by study center's Institutional review board/independent ethics committee (IRB/IEC)
• The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

Exclusion criteria

• Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements.
• History of schizophrenia, bipolar disorder, or other psychotic disorder.
• Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (ADD/ADHD) and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment.
• Currently meets DSM-IV-TR criteria for a primary mood disorder.
• Severe obsessive-compulsive disorder (OCD), per children's yale-brown obsessive compulsive scale (CY-BOCS) score >16.
• Taken aripiprazole within 30 days of the Screening visit.
• Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
• History of neuroleptic malignant syndrome.
• Sexually active participants not using 2 approved methods of contraception; breastfeeding or pregnant.
• Risk of committing suicide
• Bodyweight lower than 16 kg
• Taken neuroleptic or antiparkinson drugs <14 days prior to randomization.
• Requiring cognitive-behavioral therapy (CBT) for TD during study.
• Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
• Positive drug screen
• Participant requires medications not allowed per protocol
• Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of study.
• Inability to swallow tablets or tolerate oral medication
• Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 4 patient groups, including a placebo group

Matching Placebo

Placebo Comparator group

Description:

Participants received aripiprazole matching placebo, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.

Treatment:

Drug: Placebo

Aripiprazole 52.5 mg

Experimental group

Description:

Participants received aripiprazole 52.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.

Treatment:

Drug: Aripiprazole

Aripiprazole 77.5 mg

Experimental group

Description:

Participants received aripiprazole 77.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.

Treatment:

Drug: Aripiprazole

Aripiprazole 110 mg

Experimental group

Description:

Participants received aripiprazole 110 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.

Treatment:

Drug: Aripiprazole