Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01416441
First received: August 1, 2011
Last updated: March 18, 2014
Last verified: March 2014

August 1, 2011
March 18, 2014
August 2011
March 2014   (final data collection date for primary outcome measure)
  • Number and percentage of subjects with adverse events [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with suicidality, suicidal behavior and suicidal ideation from the potential suicide events recorded on the C-SSRS [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in EPS scales, ADD/ADHD Subscale of SNAP-IV, CY-BOCS, CDRS-R, and PARS at Weeks 4, 8, 12, 16, 20, 24, 36, 44, and 52 [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 44, and 52 ] [ Designated as safety issue: No ]
    The change from baseline at each scheduled visit will be calculated as the values at the respective scheduled visit minus the baseline values.
  • Change from baseline in body weight, waist circumference, and BMI at Weeks 12, 24, and 52 [ Time Frame: Weeks 12, 24, and 52 ] [ Designated as safety issue: No ]
    The change from baseline at each scheduled visit will be calculated as the values at the respective scheduled visit minus the baseline values.
Same as current
Complete list of historical versions of study NCT01416441 on ClinicalTrials.gov Archive Site
  • Change from Baseline to endpoint in YGTSS TTS [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Mean change from Baseline to endpoint in Total YGTSS score [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Response rates [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Treatment discontinuation rates [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tourette's Disorder
Drug: aripiprazole
Open-label Once-weekly formulation of aripiprazole as a flexible-dose regimen
Other Name: ABILIFY (aripiprazole)
Experimental: Aripiprazole
Once-weekly tablets
Intervention: Drug: aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed participation or discontinued due to lack of efficacy at week 5 or later in either Trial 31-10-272 or 31-10-273
  • 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:

  • The subject experienced AEs during the double-blind trial (31-10-272 or 31-10-273) 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 at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1
  • Sexually active patients not using 2 approved methods of contraception; breastfeeding or pregnant.
  • Risk of committing suicide
  • Body weight lower than 16 kg
  • Abnormal laboratory test results, vital signs and ECG results
Both
7 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Romania,   Taiwan,   Ukraine
 
NCT01416441
31-10-274
No
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP