Trial Outcomes & Findings for Oral Aripiprazole Open-Label Rollover Study (NCT NCT01001702)

Results Overview

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

Up to 72 months

Results posted on

2013-09-27

Participant Flow

An open-label rollover study for participants who completed study 31-03-241 (NCT00102518). The withdrawal criteria for this open label rollover study was completion by 31 December 2012 (or if Month 72 occurred within 6 months of this date) or if there was commercial availability.

Participant milestones

Participant milestones
Measure	Oral Aripiprazole Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Study STARTED	85
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Aripiprazole Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Study Lost to Follow-up	7
Overall Study Adverse Event	7
Overall Study Sponsor Discontinued Study	4
Overall Study Subject met Withdrawal Criteria	22
Overall Study Investigator withdrew Subject	10
Overall Study Withdrawal by Subject	19
Overall Study Lack of Efficacy per Investigator	3

Baseline Characteristics

Oral Aripiprazole Open-Label Rollover Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Aripiprazole n=85 Participants Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Age Continuous	16.29 years STANDARD_DEVIATION 1.36 • n=93 Participants
Sex: Female, Male Female	42 Participants n=93 Participants
Sex: Female, Male Male	43 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 72 months

Population: Safety population included all participants who received at least one dose of study drug.

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section.

Outcome measures

Outcome measures
Measure	Oral Aripiprazole n=85 Participants Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths AEs	61 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths SAEs	11 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths Discontinuation due to AEs	7 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths Death	1 Participants

SECONDARY outcome

Timeframe: Baseline, Last Visit (Up to 72 Months)

Population: Participants with baseline assessment and at least one post-baseline measurement for analysis.

The rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" 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; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement

Outcome measures

Outcome measures
Measure	Oral Aripiprazole n=84 Participants Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score	-0.26 Score on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline, Up to 72 Months

Population: Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.

Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory. Clinically significant values are defined as the following: Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase \> 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years \[Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)\]. Eosinophils ≥ 10 %. Hematocrit \< 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline. Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin \> 1 times the upper limit of normal \[Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)\].