Study Evaluating the Safety and Efficacy of Fixed-dose On... | NCT01727700

Study Evaluating the Safety and Efficacy of Fixed-dose On... | NCT01727700 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Matching Placebo Once-Daily	Drug: Placebo
Aripiprazole 5 mg or 10 mg	Experimental	Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily	Drug: Aripiprazole
Aripiprazole 10 mg or 20 mg	Experimental	Aripiprazole 10 mg 20 mg Immediate Release Once-Daily	Drug: Aripiprazole

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Once-daily, tablet	Aripiprazole 10 mg or 20 mg Aripiprazole 5 mg or 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).	The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.	Baseline to Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.	To assess CGI-TS severity, the rater or physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female, 7 to 17 year old (inclusive) at the time of signing consent
meets DSM-IV-TR diagnostic criteria for Tourette's Disorder
Presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating
Written informed consent obtained from a legally acceptable representative & informed assent at Screening as applicable by trial center's IRB/IEC
The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator

Exclusion Criteria:

Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements
History of schizophrenia, bipolar disorder, or other psychotic disorder
Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment
Currently meets DSM-IV-TR criteria for a primary mood disorder
Severe Obsessive Compulsive Disorder (OCD)
Taken aripiprazole within 30 days of the Screening visit
Received any investigational agent in a clinical trial within 30 days prior to Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with Once-daily aripiprazole at any time
History of neuroleptic malignant syndrome
Sexually active patients not using 2 approved methods of contraception
Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
Risk of committing suicide
Body weight lower than 16 kg
Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization
Requiring cognitive behavioral therapy (CBT) for Tourette's during trial
Subject meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months
Positive drug screen
Subject requires medications not allowed per protocol
Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of trial
Use of herbal medications of any kind and nutritional or dietary supplements for Tourette's disorder within 7 days prior to dosing and for the duration of the trial
Inability to swallow tablets or tolerate oral medication
Abnormal laboratory test results, vital signs and ECG results

Contacts/Locations Module

Name	Affiliation	Role
Eva Kohegyi, MD	Otsuka Pharmaceutical Development & Commercialization, Inc.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28686474	Derived	Sallee F, Kohegyi E, Zhao J, McQuade R, Cox K, Sanchez R, van Beek A, Nyilas M, Carson W, Kurlan R. Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 10.1089/cap.2016.0026. Epub 2017 Jul 7.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0017 subjects FG0021 subjects
Particpant withdrew consent		FG0000 subjects FG0013 subjects FG0021 subjects
Protocol Violation		FG0002 subjects FG0010 subjects FG0020 subjects

Arm/Group Information

ID	Title	Description
BG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
BG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
BG002	Placebo	Participants received matching placebo tablets in the same way as aripiprazole.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-13.35± 1.59 OG001-16.94± 1.61 OG002-7.09± 1.55

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation [SD] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.	Mixed Models Analysis	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	0.0020	The Hochberg procedure was used to adjust for multiplicity.	Treatment difference	-6.26			2-Sided	95	-10.18	-2.34				No

Secondary

Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.

To assess CGI-TS severity, the rater or physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 8

ID	Title	Description
OG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
OG001

Secondary

Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score

The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.

ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline to Week 8

ID	Title	Description
OG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
OG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.

Secondary

Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score

The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.

ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline to Week 8

ID	Title	Description
OG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
OG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.

Secondary

Response Rate

Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.

ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.

Posted

Number

Percentage of Responders

Week 8

ID	Title	Description
OG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
OG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.

Secondary

Treatment Discontinuation Rate

Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.

ITT Population: All participants randomly assigned to the double-blind treatment.

Posted

Number

Percentage of participants

Week 8

ID	Title	Description
OG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
OG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aripiprazole Low Dose	For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.	44	21	44
EG001	Aripiprazole High Dose	For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.	45	29	45
EG002	Placebo	Participants received matching placebo tablets in the same way as aripiprazole.	44	8	44

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0003 affected44 at risk EG0014 affected45 at risk EG0021 affected44 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0002 affected44 at risk EG0013 affected45 at risk EG0022 affected44 at risk
Fatigue	General disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0003 affected44 at risk EG0017 affected45 at risk EG0020 affected44 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0003 affected44 at risk EG0014 affected45 at risk EG0020 affected44 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0004 affected44 at risk EG0013 affected45 at risk EG0021 affected44 at risk
Akathisia	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected44 at risk EG0013 affected45 at risk EG0020 affected44 at risk
Headache	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0003 affected44 at risk EG0014 affected45 at risk EG0021 affected44 at risk
Lethargy	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected44 at risk EG0015 affected45 at risk EG0020 affected44 at risk
Sedation	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0008 affected44 at risk EG0014 affected45 at risk EG0021 affected44 at risk
Somnolence	Nervous system disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0005 affected44 at risk EG0017 affected45 at risk EG0021 affected44 at risk
Restlessness	Psychiatric disorders	MedDRA Version 16.0	Non-systematic Assessment	EG0000 affected44 at risk EG0013 affected45 at risk EG0021 affected44 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 16.0	Non-systematic Assessment	EG0001 affected44 at risk EG0011 affected45 at risk EG0023 affected44 at risk

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D065886	Neurodevelopmental Disorders
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	0.0001	The Hochberg procedure was used to adjust for multiplicity.	Treatment difference	-1.03			2-Sided	95	-1.54	-0.52				No	Superiority or Other
OG001 OG002		Mixed Models Analysis	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	0.0002	The Hochberg procedure was used to adjust for multiplicity.	Treatment difference	-1.02			2-Sided	95	-1.54	-0.49				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		0.0017	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	Treatment difference	-13.26			2-Sided	95	-21.43	-5.08				No	Superiority or Other
OG001 OG002		Mixed Models Analysis		<0.0001	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	Treatment difference	-19.37			2-Sided	95	-27.70	-11.04				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		0.0010	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	Treatment difference	-0.80			2-Sided	95	-1.27	-0.33				No	Superiority or Other
OG001 OG002		Mixed Models Analysis		0.0002	Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.	MMRM	-0.92			2-Sided	95	-1.41	-0.44				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Cochran-Mantel-Haenszel	Response ratio > 1 favors aripiprazole.	0.0835	P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.	Response ratio	1.36			2-Sided	95	0.98	1.88				No	Superiority or Other
OG001 OG002		Cochran-Mantel-Haenszel	Response ratio > 1 favors aripiprazole.	0.0014	P-value derived from CMH General Association Test adjusting for region and weight group.	Response ratio	1.61			2-Sided	95	1.20	2.16				No	Superiority or Other

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Cochran-Mantel-Haenszel	0.9187	Discontinuation ratio < 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.	Discontinuation ratio	1.16	2-Sided	95	0.19	7.05	No	Superiority or Other
OG000 OG002	Regression, Cox	0.9576	Hazard ratio < 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.	Hazard Ratio (HR)	1.05					No	Superiority or Other
OG001 OG002	Cochran-Mantel-Haenszel	0.0132	Discontinuation ratio < 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.	Discontinuation ratio	4.06	2-Sided	95	1.10	14.95	No	Superiority or Other
OG001 OG002	Regression, Cox	0.0278	Hazard ratio < 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.	Hazard Ratio (HR)	5.51					No	Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Dothan	Alabama		United States

ID	Term
D005879	Tourette Syndrome
D013981	Tic Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D020323	Tics
D009069	Movement Disorders
D001523	Mental Disorders