Trial Outcomes & Findings for Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder (NCT NCT00706589)

Last Updated: 2013-07-26

Results Overview

The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

61 participants

Primary outcome timeframe

10 week

Results posted on

2013-07-26

Participant Flow

Recruitment period :Aug2008\~Jan2010 Types of location: Medical Center

antipsychotic or antiparkinson drugs should be washed out 1\~2 weeks prior to randomization.

Participant milestones

Participant milestones
Measure	Aripiprazole Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O	Placebo Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
Overall Study STARTED	32	29
Overall Study COMPLETED	29	25
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=32 Participants Aripiprazole 2mg,5mg,10mg,15mg	Placebo n=29 Participants Placebo 2mg,5mg,10mg,15mg	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	10.97 years STANDARD_DEVIATION 2.49 • n=5 Participants	10.93 years STANDARD_DEVIATION 3.00 • n=7 Participants	10.95 years STANDARD_DEVIATION 2.72 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Korea, Republic of	32 participants n=5 Participants	29 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 week

Population: ITT (Intention-To-Treat)analysis

Outcome measures

Outcome measures
Measure	Aripiprazole n=31 Participants Aripiprazole 2mg,5mg,10mg,15mg, 20mg	Placebo n=29 Participants Placebo 2mg,5mg,10mg,15mg, 20mg
Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)	-9.62 units on a scale Interval -32.0 to 8.0	-14.97 units on a scale Interval -33.0 to 2.0

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Director

Kiho Moon

Phone: +82-2-3287-9009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Aripiprazole n=32 participants at risk Aripiprazole 2mg,5mg,10mg,15mg	Placebo n=28 participants at risk Placebo 2mg,5mg,10mg,15mg
Nervous system disorders Sedation	12.5% 4/32 • Number of events 5 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	10.7% 3/28 • Number of events 5 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Akathisia	6.2% 2/32 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	14.3% 4/28 • Number of events 5 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Headache	15.6% 5/32 • Number of events 5 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	3.6% 1/28 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Dizziness	3.1% 1/32 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	14.3% 4/28 • Number of events 4 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Extrapyramidal disorder	9.4% 3/32 • Number of events 3 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Somnolence	12.5% 4/32 • Number of events 5 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	0.00% 0/28 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Nervous system disorders Dystonia	0.00% 0/32 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Gastrointestinal disorders Nausea	18.8% 6/32 • Number of events 6 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 3 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Gastrointestinal disorders Dyspepsia	3.1% 1/32 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Gastrointestinal disorders Vomiting	0.00% 0/32 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	10.7% 3/28 • Number of events 4 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Infections and infestations Nasopharyngitis	12.5% 4/32 • Number of events 4 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	0.00% 0/28 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Infections and infestations Upper respiratory tract infection	3.1% 1/32 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Psychiatric disorders Insomnia	0.00% 0/32 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	10.7% 3/28 • Number of events 4 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
General disorders Irritability	0.00% 0/32 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	7.1% 2/28 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Metabolism and nutrition disorders Anorexia	6.2% 2/32 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	3.6% 1/28 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Metabolism and nutrition disorders Increased appetite	6.2% 2/32 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	0.00% 0/28 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
Investigations Electrocardiogram QT prolonged	6.2% 2/32 • Number of events 2 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.	3.6% 1/28 • Number of events 1 • 14 week A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.