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ABF Tourette's Disorder Post Marketing Surveillance Study

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ClinicalTrials.gov Identifier: NCT01795105
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Tourette's Disorder
Enrollment 692
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
Hide Arm/Group Description
  1. Pediatric patients 6 to 18 years of age with Tourette’s Disorder
  2. Patients who are prescribed Abilify® Tablets/Abilify® ODT treatment as per investigator’s medical judgment.
  3. Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, Abilify® ODT 10mg, 15mg)
Period Title: Overall Study
Started 692
Completed 648
Not Completed 44
Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
Hide Arm/Group Description Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage.
Overall Number of Baseline Participants 648
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>=6 years and <12 years Number Analyzed 648 participants
449
  69.3%
>=12 years and <18 years Number Analyzed 648 participants
199
  30.7%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants
Female
114
  17.6%
Male
533
  82.4%
[1]
Measure Analysis Population Description: Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value.
1.Primary Outcome
Title Frequency (n) of Subjects With Adverse Event
Hide Description Frequency (n) and Percentage(%) of subjects with Adverse event
Time Frame Follow-up at least once from baseline to 6 weeks and at least 12weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Main Surveillance Aripiprazole Long-term Surveillance
Hide Arm/Group Description:
Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.
Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
Overall Number of Participants Analyzed 648 233
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients reported for AE
50
   7.7%
19
   8.2%
Number of patients reported for ADR
42
   6.5%
14
   6.0%
2.Secondary Outcome
Title Mean Change in the TS-CGI(Tourette’s Syndrome-Clinical Global Impression-Improvement)
Hide Description

Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment

*TS-CGI scale 0=Not assessed

  1. Normal, not at all ill
  2. Borderline ill
  3. Mildly ill
  4. Moderately ill
  5. Markedly ill
  6. Severely ill
  7. Extremely ill
Time Frame at least 6, 12 weeks interval from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Main Surveillance Aripiprazole Long-term Surveillance
Hide Arm/Group Description:
Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.
Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
Overall Number of Participants Analyzed 589 233
Mean (Standard Deviation)
Unit of Measure: score on a scale
at the first visit 4.31  (0.81) 4.34  (0.86)
at the last visit 2.73  (0.83) 2.66  (0.80)
Mean change in the TS-CGI -1.58  (0.95) -1.69  (0.93)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Aripiprazole (Abilify® Tablets/Abilify® ODT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole (Abilify® Tablets/Abilify® ODT)
Affected / at Risk (%) # Events
Total   1/648 (0.15%)    
Nervous system disorders   
Neuritis  1/648 (0.15%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole (Abilify® Tablets/Abilify® ODT)
Affected / at Risk (%) # Events
Total   49/648 (7.56%)    
Gastrointestinal disorders   
Nausea  9/648 (1.39%)  10
Dyspepsia  2/648 (0.31%)  2
Mouth dry  1/648 (0.15%)  1
Vomiting  1/648 (0.15%)  1
Constipation  1/648 (0.15%)  1
Diarrhoea  1/648 (0.15%)  1
Enteritis  1/648 (0.15%)  1
General disorders   
Fatigue  1/648 (0.15%)  1
Metabolism and nutrition disorders   
Weight increase  1/648 (0.15%)  1
Nervous system disorders   
Extrapyramidal disorder  4/648 (0.62%)  5
Hyperkinesia  3/648 (0.46%)  3
Hypertonia  2/648 (0.31%)  2
Headache  2/648 (0.31%)  2
Dizziness  2/648 (0.31%)  2
Tremor  1/648 (0.15%)  1
Psychiatric disorders   
Somnolence  16/648 (2.47%)  16
Appetite increased  4/648 (0.62%)  4
Anorexia  2/648 (0.31%)  2
Apathy  1/648 (0.15%)  1
Nervousness  2/648 (0.31%)  2
Emotional liability  1/648 (0.15%)  1
Anxiety  1/648 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1/648 (0.15%)  1
Pharyngitis  1/648 (0.15%)  1
Skin and subcutaneous tissue disorders   
Eczema  1/648 (0.15%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeong, Hyo-Won
Organization: KoreaOtsukaPharma
EMail: jhw0159@otsuka.co.kr
Layout table for additonal information
Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01795105     History of Changes
Other Study ID Numbers: 031-KOA-1101n
First Submitted: January 31, 2013
First Posted: February 20, 2013
Results First Submitted: January 14, 2018
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019