Trial Outcomes & Findings for Lurasidone Extended Use Study (NCT NCT01485640)

NCT ID: NCT01485640

Last Updated: 2016-11-04

Results Overview

Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 162 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2016-11-04

Participant Flow

Participant milestones

Measure	Lurasidone Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Overall Study STARTED	162
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	122

Reasons for withdrawal

Measure	Lurasidone Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Overall Study Adverse Event	10
Overall Study Lack of Efficacy	2
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	14
Overall Study Terminated by Sponsor	95

Baseline Characteristics

Lurasidone Extended Use Study

Baseline characteristics by cohort

Measure	Lurasidone n=162 Participants Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	159 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	41.3 years STANDARD_DEVIATION 12.08 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Region of Enrollment Serbia	6 participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants
Region of Enrollment Czech Republic	25 participants n=5 Participants
Region of Enrollment Slovakia	17 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants
Region of Enrollment Ukraine	11 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants
Region of Enrollment Lithuania	8 participants n=5 Participants
Region of Enrollment Russian Federation	20 participants n=5 Participants
Region of Enrollment South Africa	26 participants n=5 Participants
Region of Enrollment Colombia	6 participants n=5 Participants
Region of Enrollment India	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Safety Population - subjects who took at least one dose of study medication

Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Outcome measures

Measure	Lurasidone n=162 Participants Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs Subject with at least on treatment emergent AE	63 participants
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs Subject with at least one treatment emergent SAE	7 participants
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs Subjects discontinued due to TEAE	10 participants

SECONDARY outcome

Timeframe: 18 months

Population: Only 153 subjects who had baseline and at least one post-baseline assessments.

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

Measure	Lurasidone n=153 Participants Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S	-0.18 units on a scale Standard Deviation 0.877

Adverse Events

Lurasidone

Serious events: 7 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lurasidone n=162 participants at risk Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Infections and infestations Pilonidal cyst	0.62% 1/162 • Number of events 1 • 18 Months
Injury, poisoning and procedural complications Foot fracture	0.62% 1/162 • Number of events 1 • 18 Months
Psychiatric disorders Depression	0.62% 1/162 • Number of events 1 • 18 Months
Psychiatric disorders Depression suicidal	0.62% 1/162 • Number of events 1 • 18 Months
Psychiatric disorders Mania	1.2% 2/162 • Number of events 2 • 18 Months
Psychiatric disorders Schizophrenia, paranoid type	0.62% 1/162 • Number of events 1 • 18 Months

Other adverse events

Measure	Lurasidone n=162 participants at risk Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Gastrointestinal disorders Diarrhoea	3.7% 6/162 • Number of events 8 • 18 Months
Gastrointestinal disorders Vomiting	3.1% 5/162 • Number of events 11 • 18 Months
Gastrointestinal disorders Nausea	2.5% 4/162 • Number of events 4 • 18 Months
Infections and infestations Influenza	3.7% 6/162 • Number of events 6 • 18 Months
Infections and infestations Nasopharyngitis	3.7% 6/162 • Number of events 9 • 18 Months
Infections and infestations Viral upper respiratory tract infection	2.5% 4/162 • Number of events 4 • 18 Months
Investigations Hepatic enzyme increase	2.5% 4/162 • Number of events 4 • 18 Months
Nervous system disorders Headache	5.6% 9/162 • Number of events 12 • 18 Months
Psychiatric disorders Anxiety	3.1% 5/162 • Number of events 11 • 18 Months
Psychiatric disorders Insomnia	3.1% 5/162 • Number of events 6 • 18 Months
Psychiatric disorders Depression	2.5% 4/162 • Number of events 4 • 18 Months

Additional Information

Medical Director

Sunovion

Phone: 1-866-503-6351

Email: clinicaltrialdisclosure@sunvion.com

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