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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tourette's Disorder

Intervention: aripiprazole 52.5 mg (Drug); Matching Placebo (Drug); Aripiprazole 77.5 mg (Drug); Aripiprazole 110 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Eva Kohegyi, MD, Study Director, Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.

Summary

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

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Primary efficacy measure is change from Baseline to endpoint (week 8) of the Yale Global Tic Severity Scale (YGTSS).

Secondary outcome: The key secondary efficacy endpoints will be the CGI-TS change score at endpoint (week 8) (change score obtained from CGI-TS improvement scale assessment) and the mean changes from Baseline to endpoint (week 8) in GTS-QOL overall score.

Eligibility

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 7 to 17 year old, male or female with DSM-IV-TR diagnostic criteria for TD, confirmed

by the KSADS-PL, including the Diagnostic Supplement 5

- Has a TTS ≥ 20 on the YGTSS at Screening and Baseline

- 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 must have a negative pregnancy test, must be

practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating.

- Written ICF obtained from a legally acceptable representative & informed assent at

Screening as applicable by trial center's IRB/IEC

- The subject, 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.

- Subject receiving psychostimulants for treatment of 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 OCD, per 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 patients not using 2 approved methods of contraception; breastfeeding

or pregnant.

- Risk of committing suicide

- Body weight lower than 16 kg

- Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization.

- Requiring CBT for TD during trial.

- Subject meets DSM-IV-TR criteria for any significant psychoactive substance use

disorder within the past 3 months.

- Positive drug screen

- Subject 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 trial

- Inability to swallow tablets or tolerate oral medication

- Abnormal laboratory test results, vital signs and ECG results

Locations and Contacts

Ruse 7004, Bulgaria

Sofia 1431, Bulgaria

Varna 9010, Bulgaria

Aachen 52074, Germany

Dresden 01307, Germany

Hannover 30625, Germany

Muenchen 80336, Germany

Ulm 89075, Germany

Bucuresti 041914, Romania

Cluj-Napoca 400660, Romania

Craiova 200620, Romania

Iasi 700282, Romania

Donetsk 83008, Ukraine

Kharkiv 61068, Ukraine

Kharkiv 61153, Ukraine

Kyiv 01030, Ukraine

Kyiv 03049, Ukraine

Kyiv 04209, Ukraine

Lugansk 91045, Ukraine

Poltava 36006, Ukraine

s. Stepanivka, Kherson 73488, Ukraine

Vinnytsia 21005, Ukraine

Dothan, Alabama 36303, United States

San Francisco, California 94143, United States

Gainesville, Florida 32610, United States

Miami, Florida 33126, United States

Atlanta, Georgia 30308, United States

Atlanta, Georgia 30329, United States

Chicago, Illinois 60612, United States

Omaha, Nebraska 68131, United States

Manhasset, New York 11030, United States

Cincinnati, Ohio 45229-3039, United States

Oklahoma City, Oklahoma 73112, United States

Charlottesville, Virginia 22903, United States

La Crosse, Wisconsin 54601, United States

Additional Information

Starting date: July 2011
Last updated: May 6, 2015

Page last updated: August 20, 2015

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