Tourette's Disorder
Conditions
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).
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.
Interventions
None listed
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Extremely ill |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole (Abilify® Tablets/Abilify® ODT) Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage. | 648 |
| Total | 648 |
Baseline characteristics
| Characteristic | Aripiprazole (Abilify® Tablets/Abilify® ODT) |
|---|---|
| Age, Customized >=12 years and <18 years | 199 Participants |
| Age, Customized >=6 years and <12 years | 449 Participants |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 533 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 648 |
| serious Total, serious adverse events | 1 / 648 |
Outcome results
Primary
Frequency (n) of Subjects With Adverse Event
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aripiprazole Main Surveillance | Frequency (n) of Subjects With Adverse Event | Number of patients reported for AE | 50 Participants |
| Aripiprazole Main Surveillance | Frequency (n) of Subjects With Adverse Event | Number of patients reported for ADR | 42 Participants |
| Aripiprazole Long-term Surveillance | Frequency (n) of Subjects With Adverse Event | Number of patients reported for AE | 19 Participants |
| Aripiprazole Long-term Surveillance | Frequency (n) of Subjects With Adverse Event | Number of patients reported for ADR | 14 Participants |
Secondary
Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole Main Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | at the first visit | 4.31 score on a scale | Standard Deviation 0.81 |
| Aripiprazole Main Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | at the last visit | 2.73 score on a scale | Standard Deviation 0.83 |
| Aripiprazole Main Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | Mean change in the TS-CGI | -1.58 score on a scale | Standard Deviation 0.95 |
| Aripiprazole Long-term Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | Mean change in the TS-CGI | -1.69 score on a scale | Standard Deviation 0.93 |
| Aripiprazole Long-term Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | at the last visit | 2.66 score on a scale | Standard Deviation 0.8 |
| Aripiprazole Long-term Surveillance | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | at the first visit | 4.34 score on a scale | Standard Deviation 0.86 |