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

This study is currently recruiting participants.
Verified February 2013 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01418352
First received: August 1, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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
 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 Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Resource links provided by NLM:

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 ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching Placebo Drug: aripiprazole
Fixed dose of once-weekly aripiprazole tablets or matching placebo tablets for 8 weeks
Other Name: ABILIFY (aripiprazole)
Experimental: Group A: Aripiprazole
Subjects will be randomized to one of three doses of aripiprazole or matching placebo tablets in a double-blind fashion of 1:1:1:1 ratio. The randomized doses will be achieved after a mandatory titration schedule (after 1-3 weeks depending on the randomized dose).
 Drug: aripiprazole
Fixed dose of once-weekly aripiprazole tablets or matching placebo tablets for 8 weeks
Other Name: ABILIFY (aripiprazole)
Experimental: Group B: Aripiprazole
Subjects will be randomized to one of three doses of aripiprazole or matching placebo tablets in a double-blind fashion of 1:1:1:1 ratio. The randomized doses will be achieved after a mandatory titration schedule (after 1-3 weeks depending on the randomized dose).
 Drug: aripiprazole
Fixed dose of once-weekly aripiprazole tablets or matching placebo tablets for 8 weeks
Other Name: ABILIFY (aripiprazole)
Experimental: Group C: Aripiprazole
Subjects will be randomized to one of three doses of aripiprazole or matching placebo tablets in a double-blind fashion of 1:1:1:1 ratio. The randomized doses will be achieved after a mandatory titration schedule (after 1-3 weeks depending on the randomized dose).
 Drug: aripiprazole
Fixed dose of once-weekly aripiprazole tablets or matching placebo tablets for 8 weeks
Other Name: ABILIFY (aripiprazole)

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418352

Contacts
Contact: CenterWatch tourettes@centerwatch.com

  Show 42 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01418352     History of Changes
Other Study ID Numbers: 31-10-273
Study First Received: August 1, 2011
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Romania: National Medicines Agency
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Tourette's Disorder
tic disorders

Additional relevant MeSH terms:
Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
 Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013