Trial Outcomes & Findings for ITI-007 (Lumateperone Tosylate) for Schizophrenia (NCT NCT03817528)

Last Updated: 2021-11-04

Results Overview

schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Change from baseline in Total PANSS score after 6 month treatment

Results posted on

2021-11-04

Participant Flow

Enrollment reflects the number of participants were deemed eligible and received study drug

Participants underwent a screening phase to determine eligibility to receive study medication

Participant milestones

Participant milestones
Measure	ITI-007 Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ITI-007 Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	2

Baseline Characteristics

ITI-007 (Lumateperone Tosylate) for Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ITI-007 n=4 Participants Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline in Total PANSS score after 6 month treatment

Population: Completed participants (6 months of treatment). Outcome measure reported as change in PANSS score from baseline to end of treatment

Outcome measures

Outcome measures
Measure	ITI-007 n=1 Participants Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Schizophrenia Symptoms	11 change in PANSS score from baseline

Adverse Events

ITI-007

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ITI-007 n=8 participants at risk Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Psychiatric disorders worsening of symptoms	12.5% 1/8 • Number of events 1 • Adverse events to be reported from time of consent (whether received study drug or not) to 30 days after completion of study treatment (up to 8 months) AE/SAE collection from all individuals who signed informed consent (total: 8)

Other adverse events

Other adverse events
Measure	ITI-007 n=8 participants at risk Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Psychiatric disorders hypomania	12.5% 1/8 • Number of events 1 • Adverse events to be reported from time of consent (whether received study drug or not) to 30 days after completion of study treatment (up to 8 months) AE/SAE collection from all individuals who signed informed consent (total: 8)
Gastrointestinal disorders vomiting	12.5% 1/8 • Number of events 1 • Adverse events to be reported from time of consent (whether received study drug or not) to 30 days after completion of study treatment (up to 8 months) AE/SAE collection from all individuals who signed informed consent (total: 8)

Additional Information

Marlene Carlson, MPH

New York State Psychiatric Institute

Phone: 646-774-5340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place