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

Purpose

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.

Condition	Intervention	Phase
Tourette's Disorder	Drug: aripiprazole Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Flexible-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

Primary efficacy measure is change from Baseline to endpoint (week 8) of the Yale Global Tic Severity Scale (YGTSS). [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]


Enrollment:	135
Study Start Date:	July 2011
Study Completion Date:	January 2014
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Matching Placebo Once weekly matching placebo	Drug: Placebo Dose of matching placebo tablets for 8 weeks
Experimental: Aripiprazole Once-weekly tablets	Drug: aripiprazole Flexible dose of once-weekly aripiprazole tablets Other Name: ABILIFY (aripiprazole)

Eligibility


Ages Eligible for Study:	7 Years to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

7 to 17 year old with DSM-IV-TR diagnostic criteria for TD, confirmed by the K-SADS-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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418339

Show 39 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators


Study Director:	Eva Kohegyi, MD	Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information


Responsible Party:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT01418339 History of Changes
Other Study ID Numbers:	31-10-272
Study First Received:	August 1, 2011
Last Updated:	November 4, 2014
Health Authority:	United States: Food and Drug Administration Hungary: National Institute of Pharmacy Canada: Health Canada Taiwan: Department of Health Taiwan: Center for Drug Evaluation South Korea: Korea Food and Drug Administration (KFDA) Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:


Tourette's Disorder tic disorders

Additional relevant MeSH terms:


Disease Tourette Syndrome 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 Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs

ClinicalTrials.gov processed this record on September 27, 2016