ABF Tourette's Disorder Post Marketing Surveillance Study
Study Details
Study Description
Brief Summary
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Aripiprazole (Abilify® Tablets/Abilify® ODT)
|
Outcome Measures
Primary Outcome Measures
- Frequency (n) of Subjects With Adverse Event [Follow-up at least once from baseline to 6 weeks and at least 12weeks]
Frequency (n) and Percentage(%) of subjects with Adverse event
Secondary Outcome Measures
- Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) [at least 6, 12 weeks interval from baseline]
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 Normal, not at all ill Borderline ill Mildly ill Moderately ill Markedly ill Severely ill Extremely ill
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pediatric patients 6 to 18 years of age with Tourette's Disorder
-
Patients who are prescribed Abilify® treatment as per investigator's medical judgment.
-
Patients who gave written authorization to use their personal and health data
-
Patients starting Abilify® treatment after agreement is in place
Exclusion Criteria:
-
Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®
-
Patients who have been treated with Abilify®
-
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption
-
Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S
-
Patients participating in other clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inha University Hospital | Incheon | Korea, Republic of | ||
| 2 | Chonbuk National University Hospital | Jeonju | Korea, Republic of | 561-712 | |
| 3 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 | |
| 4 | Seoul Medical Center | Seoul | Korea, Republic of | 131-795 |
Sponsors and Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 031-KOA-1101n
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Aripiprazole (Abilify® Tablets/Abilify® ODT) |
|---|---|
| Arm/Group Description | Pediatric patients 6 to 18 years of age with Tourette's Disorder Patients who are prescribed Abilify® Tablets/Abilify® ODT treatment as per investigator's medical judgment. Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, Abilify® ODT 10mg, 15mg) |
| Period Title: Overall Study | |
| STARTED | 692 |
| COMPLETED | 648 |
| NOT COMPLETED | 44 |
Baseline Characteristics
| Arm/Group Title | Aripiprazole (Abilify® Tablets/Abilify® ODT) |
|---|---|
| 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 Participants | 648 |
| Age, Customized (Count of Participants) | |
| >=6 years and <12 years |
449
69.3%
|
| >=12 years and <18 years |
199
30.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
114
17.6%
|
| Male |
533
82.3%
|
Outcome Measures
| Title | Frequency (n) of Subjects With Adverse Event |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aripiprazole Main Surveillance | Aripiprazole Long-term Surveillance |
|---|---|---|
| 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. |
| Measure Participants | 648 | 233 |
| Number of patients reported for AE |
50
7.7%
|
19
NaN
|
| Number of patients reported for ADR |
42
6.5%
|
14
NaN
|
| Title | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) |
|---|---|
| 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 Normal, not at all ill Borderline ill Mildly ill Moderately ill Markedly ill Severely ill Extremely ill |
| Time Frame | at least 6, 12 weeks interval from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aripiprazole Main Surveillance | Aripiprazole Long-term Surveillance |
|---|---|---|
| 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. |
| Measure Participants | 589 | 233 |
| 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)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Aripiprazole (Abilify® Tablets/Abilify® ODT) | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Aripiprazole (Abilify® Tablets/Abilify® ODT) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Aripiprazole (Abilify® Tablets/Abilify® ODT) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/648 (0.2%) | |
| Nervous system disorders | ||
| Neuritis | 1/648 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Aripiprazole (Abilify® Tablets/Abilify® ODT) | ||
| Affected / at Risk (%) | # Events | |
| Total | 49/648 (7.6%) | |
| Gastrointestinal disorders | ||
| Nausea | 9/648 (1.4%) | 10 |
| Dyspepsia | 2/648 (0.3%) | 2 |
| Mouth dry | 1/648 (0.2%) | 1 |
| Vomiting | 1/648 (0.2%) | 1 |
| Constipation | 1/648 (0.2%) | 1 |
| Diarrhoea | 1/648 (0.2%) | 1 |
| Enteritis | 1/648 (0.2%) | 1 |
| General disorders | ||
| Fatigue | 1/648 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||
| Weight increase | 1/648 (0.2%) | 1 |
| Nervous system disorders | ||
| Extrapyramidal disorder | 4/648 (0.6%) | 5 |
| Hyperkinesia | 3/648 (0.5%) | 3 |
| Hypertonia | 2/648 (0.3%) | 2 |
| Headache | 2/648 (0.3%) | 2 |
| Dizziness | 2/648 (0.3%) | 2 |
| Tremor | 1/648 (0.2%) | 1 |
| Psychiatric disorders | ||
| Somnolence | 16/648 (2.5%) | 16 |
| Appetite increased | 4/648 (0.6%) | 4 |
| Anorexia | 2/648 (0.3%) | 2 |
| Apathy | 1/648 (0.2%) | 1 |
| Nervousness | 2/648 (0.3%) | 2 |
| Emotional liability | 1/648 (0.2%) | 1 |
| Anxiety | 1/648 (0.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Epistaxis | 1/648 (0.2%) | 1 |
| Pharyngitis | 1/648 (0.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Eczema | 1/648 (0.2%) | 1 |
Limitations/Caveats
More Information
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
| Name/Title | Jeong, Hyo-Won |
|---|---|
| Organization | KoreaOtsukaPharma |
| Phone | |
| jhw0159@otsuka.co.kr |
- 031-KOA-1101n