Trial Outcomes & Findings for ABF Tourette's Disorder Post Marketing Surveillance Study (NCT NCT01795105)

NCT ID: NCT01795105

Last Updated: 2019-04-01

Results Overview

Frequency (n) and Percentage(%) of subjects with Adverse event

• Recruitment status: COMPLETED
• Target enrollment: 692 participants
• Primary outcome timeframe: Follow-up at least once from baseline to 6 weeks and at least 12weeks
• Results posted on: 2019-04-01

Participant Flow

Participant milestones

Measure	Aripiprazole (Abilify® Tablets/Abilify® ODT) 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)
Overall Study STARTED	692
Overall Study COMPLETED	648
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value.

Baseline characteristics by cohort

Measure	Aripiprazole (Abilify® Tablets/Abilify® ODT) n=648 Participants Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage.
Age, Customized >=6 years and <12 years	449 Participants n=648 Participants
Age, Customized >=12 years and <18 years	199 Participants n=648 Participants
Sex: Female, Male Female	114 Participants n=647 Participants • Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value.
Sex: Female, Male Male	533 Participants n=647 Participants • Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value.

PRIMARY outcome

Timeframe: Follow-up at least once from baseline to 6 weeks and at least 12weeks

Frequency (n) and Percentage(%) of subjects with Adverse event

Outcome measures

Measure	Aripiprazole Main Surveillance n=648 Participants Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.	Aripiprazole Long-term Surveillance n=233 Participants Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
Frequency (n) of Subjects With Adverse Event Number of patients reported for AE	50 Participants	19 Participants
Frequency (n) of Subjects With Adverse Event Number of patients reported for ADR	42 Participants	14 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Aripiprazole Main Surveillance n=589 Participants Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.	Aripiprazole Long-term Surveillance n=233 Participants Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
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	2.66 score on a scale Standard Deviation 0.80
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	4.34 score on a scale Standard Deviation 0.86
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	-1.69 score on a scale Standard Deviation 0.93

Adverse Events

Aripiprazole (Abilify® Tablets/Abilify® ODT)

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aripiprazole (Abilify® Tablets/Abilify® ODT) n=648 participants at risk
Nervous system disorders Neuritis	0.15% 1/648 • Number of events 1

Other adverse events

Measure	Aripiprazole (Abilify® Tablets/Abilify® ODT) n=648 participants at risk
Psychiatric disorders Somnolence	2.5% 16/648 • Number of events 16
Psychiatric disorders Appetite increased	0.62% 4/648 • Number of events 4
Psychiatric disorders Anorexia	0.31% 2/648 • Number of events 2
Psychiatric disorders Apathy	0.15% 1/648 • Number of events 1
Psychiatric disorders Nervousness	0.31% 2/648 • Number of events 2
Psychiatric disorders Emotional liability	0.15% 1/648 • Number of events 1
Psychiatric disorders Anxiety	0.15% 1/648 • Number of events 1
Gastrointestinal disorders Nausea	1.4% 9/648 • Number of events 10
Gastrointestinal disorders Dyspepsia	0.31% 2/648 • Number of events 2
Gastrointestinal disorders Mouth dry	0.15% 1/648 • Number of events 1
Gastrointestinal disorders Vomiting	0.15% 1/648 • Number of events 1
Gastrointestinal disorders Constipation	0.15% 1/648 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.15% 1/648 • Number of events 1
Gastrointestinal disorders Enteritis	0.15% 1/648 • Number of events 1
Nervous system disorders Extrapyramidal disorder	0.62% 4/648 • Number of events 5
Nervous system disorders Hyperkinesia	0.46% 3/648 • Number of events 3
Nervous system disorders Hypertonia	0.31% 2/648 • Number of events 2
Nervous system disorders Headache	0.31% 2/648 • Number of events 2
Nervous system disorders Dizziness	0.31% 2/648 • Number of events 2
Nervous system disorders Tremor	0.15% 1/648 • Number of events 1
Respiratory, thoracic and mediastinal disorders Epistaxis	0.15% 1/648 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.15% 1/648 • Number of events 1
Metabolism and nutrition disorders Weight increase	0.15% 1/648 • Number of events 1
General disorders Fatigue	0.15% 1/648 • Number of events 1
Skin and subcutaneous tissue disorders Eczema	0.15% 1/648 • Number of events 1

Additional Information

Jeong, Hyo-Won

KoreaOtsukaPharma

Email: jhw0159@otsuka.co.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place