Trial Outcomes & Findings for A Twelve Week, Open Label Extension Study in Patients With Schizophrenia (NCT NCT01566162)

Results Overview

Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

191 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Lurasidone Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Overall Study STARTED	191
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lurasidone n=191 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Age, Continuous	42.7 Years STANDARD_DEVIATION 12.30 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants
Region of Enrollment Serbia	22 participants n=5 Participants
Region of Enrollment France	4 participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants
Region of Enrollment Slovakia	15 participants n=5 Participants
Region of Enrollment Russia	19 participants n=5 Participants
Region of Enrollment South Africa	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)

Outcome measures

Outcome measures
Measure	Lurasidone n=191 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) Subjects with TEAEs	72 participants
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) TEASs leading to discontinuation	7 participants
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) Subjects with TESAEs	13 participants

PRIMARY outcome

Timeframe: Baseline to week 12 LOCF endpoint

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

Outcome measures

Outcome measures
Measure	Lurasidone n=191 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score	-8.4 units on a scale Standard Deviation 15.06

PRIMARY outcome

Timeframe: Baseline to week 12 LOCF endpoint

The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

Outcome measures

Outcome measures
Measure	Lurasidone n=191 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.	-0.48 units on a scale Standard Deviation 1.051

SECONDARY outcome

Timeframe: Baseline to week 12 LOCF endpoint

Population: Only 182 subjects had post-baseline MADRS assessments.

The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

Outcome measures

Outcome measures
Measure	Lurasidone n=182 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score	-3.3 units on a scale Standard Deviation 7.83

SECONDARY outcome

Timeframe: Baseline to week 12 LOCF endpoint

Population: Only 182 subjects had post-baseline SF-12.v2 assessments.

The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Lurasidone n=182 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Short Form-12 Health Survey (SF-12)	-0.45 units on a scale Standard Deviation 6.642

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 174 subjects had SLOF assessments at week 12 LOCF.

The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.

Outcome measures

Outcome measures
Measure	Lurasidone n=174 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Modified Specific Levels of Functioning (SLOF) Total Score.	-1.8 units on a scale Standard Deviation 9.55

SECONDARY outcome

Timeframe: 12 weeks

The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.

Outcome measures

Outcome measures
Measure	Lurasidone n=182 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Brief Adherence Rating Scale (BARS)	99.0 percentage of monthly doses taken Standard Deviation 3.08

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 36 subjects who were smokers had the smoker questionnaire assessments.

Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).

Outcome measures

Outcome measures
Measure	Lurasidone n=36 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Smoking Questionnaire	11.1 number of cigarettes smoked daily Standard Deviation 9.95

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 1825 subjects answered the questionnaire.

The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"

Outcome measures

Outcome measures
Measure	Lurasidone n=185 Participants Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Intent to Attend Assessment	8.3 units on a scale Standard Deviation 1.14

Adverse Events

Lurasidone

Serious events: 13 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lurasidone n=191 participants at risk Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Cardiac disorders Artrial flutter	0.52% 1/191 • Number of events 1 • 12 Weeks
General disorders Chest Pain	0.52% 1/191 • Number of events 1 • 12 Weeks
Infections and infestations Pneumonia	0.52% 1/191 • Number of events 1 • 12 Weeks
Psychiatric disorders Schizophrenia	3.1% 6/191 • Number of events 6 • 12 Weeks
Psychiatric disorders Psychotic Disorder	2.1% 4/191 • Number of events 5 • 12 Weeks
Vascular disorders Hypotension	0.52% 1/191 • Number of events 1 • 12 Weeks

Other adverse events

Other adverse events
Measure	Lurasidone n=191 participants at risk Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily
Gastrointestinal disorders Diarrhoea	2.1% 4/191 • Number of events 4 • 12 Weeks
Gastrointestinal disorders Nausea	2.1% 4/191 • Number of events 5 • 12 Weeks
Infections and infestations Nasopharyngitis	2.6% 5/191 • Number of events 5 • 12 Weeks
Nervous system disorders Akathisia	5.2% 10/191 • Number of events 10 • 12 Weeks
Nervous system disorders Headache	2.1% 4/191 • Number of events 5 • 12 Weeks
Psychiatric disorders Schizophrenia	4.2% 8/191 • Number of events 8 • 12 Weeks
Psychiatric disorders Anxiety	2.1% 4/191 • Number of events 9 • 12 Weeks
Psychiatric disorders Insomnia	2.1% 4/191 • Number of events 4 • 12 Weeks

Additional Information

Medical Director CNS Clinical Trials

Sunovion

Phone: 1-866-503-6351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.
Publication restrictions are in place

Restriction type: OTHER