Tourette's DisorderNCT01795105

ABF Tourette's Disorder Post Marketing Surveillance Study

An observational study of Tourette's Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Tourette's Disorder
How many people: 692 participants
Where: 4 sitesSouth Korea
Study dates: Jun 2012to 29 May 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

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

Other trials in South Korea

About this study

Official title: Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"

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: Tourette's Disorder
Medical subject headings: Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01795105
Study group	Role	What they receive
Aripiprazole (Abilify® Tablets/Abilify® ODT)		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency (n) of Subjects With Adverse Event
Frequency (n) and Percentage(%) of subjects with Adverse event
Measured: Follow-up at least once from baseline to 6 weeks and at least 12weeks

Secondary outcomes (1)

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
Measured: at least 6, 12 weeks interval from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201229 May 2015

First posted20 Feb 2013 (estimated)
Study startJun 2012
Primary completion29 May 2015
Study completion29 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tourette's DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 692 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01795105
Sponsor's protocol ID: 031-KOA-1101n
Status last verified: Jan 2018
First submitted: 31 Jan 2013
Last updated: 1 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome

All Tourette's Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
ClinicalTrials.gov ID: NCT01795105
Acronym / sponsor ID: 031-KOA-1101n
Conditions: Tourette's Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 692 participants (actual)
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: 29 May 2015 (actual)
Study completion: 29 May 2015 (actual)
First posted: 20 Feb 2013 (estimated)
Results: Posted 1 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Aripiprazole (Abilify® Tablets/Abilify® ODT)	–	–

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Frequency (n) of Subjects With Adverse Event
Time frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks
Frequency (n) and Percentage(%) of subjects with Adverse event

1 secondary outcome

Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
Time frame: at least 6, 12 weeks interval from baseline

Results and safety

Results posted to the registry on 1 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole (Abilify® Tablets/Abilify® ODT)	692	648

Primary outcome: Frequency (n) of Subjects With Adverse Event

Time frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks. Count of participants. Unit: Participants

Measure	Aripiprazole Main Surveillance n = 648	Aripiprazole Long-term Surveillance n = 233
Number of patients reported for AE	50	19
Number of patients reported for ADR	42	14

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole (Abilify® Tablets/Abilify® ODT)	1 of 648 (0.2%)	49 of 648 (7.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Tourette's Disorder

Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tourette's Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency (n) of Subjects With Adverse Event (time frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01795105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.