Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01727713
First received: November 12, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Tourette's Disorder
Tic Disorder
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number and percentage of subjects with adverse events [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
  • Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale(YGTSS) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  • The long-term effect of Once-daily aripiprazole measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Aripiprazole Immediate Release Once-Daily
Drug: Aripiprazole
Open Label: Once-Daily formulation of aripiprazole flex dose regimine
Other Name: Abilify

Detailed Description:

Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain additional efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial is a 52-week extension to the double-blind trial.

The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed participation in Trial 31-12-293
  • Written ICF obtained from a legally acceptable representative & informed assent at Baseline 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:

  • Experienced AEs during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
  • The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
  • A positive drug screen
  • Sexually active patients not using 2 approved methods of contraception
  • Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
  • Risk of committing suicide
  • Body weight lower than 16 kg
  • Abnormal laboratory test results, vital signs and ECG results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727713

  Show 34 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: NCT01727713     History of Changes
Other Study ID Numbers: 31-12-294
Study First Received: November 12, 2012
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Hungary: National Institute of Pharmacy
Italy: Ministry of Health

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Tic Disorders
Tics
Movement Disorders
Mental Disorders
Aripiprazole

Additional relevant MeSH terms:
Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
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 April 17, 2014