CompletedNCT01795105Updated Apr 1, 2019Results posted

ABF Tourette's Disorder Post Marketing Surveillance Study

An observational study in Tourette's Disorder, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Completed at 4 sites in Korea, Republic of. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-01.

Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 692
Ages: 6 Years to 18 Years
Sex: All

Study 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).

Read the 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.

Conditions studied

Tourette's Disorder

Browse trials for

Tourette Syndrome 220

In context

Tourette Syndrome

220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.

This study's enrollment of 692 is above the median of 60 across 43 observational studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization

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

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 692 participants (actual)

Groups and cohorts

Aripiprazole (Abilify® Tablets/Abilify® ODT)

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Apr 1, 2019

Participant flow

Participant flow — Overall Study
Milestone	Aripiprazole (Abilify® Tablets/Abilify® ODT)
Started	692
Completed	648
Not completed	44

Outcome measures

PrimaryFrequency (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
Reported as:: Count of participants · Participants

Frequency (n) of Subjects With Adverse Event
Participants	Aripiprazole Main Surveillance	Aripiprazole Long-term Surveillance
Number of patients reported for AE	50	19
Number of patients reported for ADR	42	14

SecondaryMean 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
Reported as:: Mean · score on a scale

Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
score on a scale	Aripiprazole Main Surveillance	Aripiprazole Long-term Surveillance
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

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aripiprazole (Abilify® Tablets/Abilify® ODT)	—	1/648 (0.2%)	49/648 (7.6%)

Most frequent serious events

Most frequent serious events
Event	Aripiprazole (Abilify® Tablets/Abilify® ODT)
NeuritisNervous system disorders	1/648

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Aripiprazole (Abilify® Tablets/Abilify® ODT)
SomnolencePsychiatric disorders	16/648
NauseaGastrointestinal disorders	9/648
Appetite increasedPsychiatric disorders	4/648
Extrapyramidal disorderNervous system disorders	4/648
HyperkinesiaNervous system disorders	3/648
AnorexiaPsychiatric disorders	2/648
NervousnessPsychiatric disorders	2/648
DyspepsiaGastrointestinal disorders	2/648
HypertoniaNervous system disorders	2/648
HeadacheNervous system disorders	2/648

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Aripiprazole (Abilify® Tablets/Abilify® ODT)
>=6 years and <12 years	449
>=12 years and <18 years	199

Sex: Female, Male
Sex: Female, Male(Participants)	Aripiprazole (Abilify® Tablets/Abilify® ODT)
Female	114
Male	533

Study locations

4 sites

Inha University Hospital
Incheon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, 561-712, Korea, Republic of
Seoul National University Hospital
Seoul, 110-744, Korea, Republic of
Seoul Medical Center
Seoul, 131-795, Korea, Republic of

References and documents

Study documents

Study protocol · Feb 28, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01795105
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Feb 20, 2013
Start date: Jun 2012
Primary completion: May 29, 2015
Completion: May 29, 2015
Results posted: Apr 1, 2019
Last update: Apr 1, 2019

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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