A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

April 18, 2022 updated by: Sirtsei Pharmaceuticals, Inc.

A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Research
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Is willing and able to provide written informed consent to participate in the study.
  • Has an identified reliable informant.

  • Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.

    • Subjects must meet screening eligibility criteria and be in an inpatient setting prior to discontinuing antipsychotic medications.
    • Subject must be able, in the investigator's opinion, to safely discontinue prohibited psychotropic medications prior to Baseline without increased suicidality.
  • Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
  • Is experiencing an acute exacerbation or relapse of symptoms.
  • Is in generally good physical health, in the investigator's opinion, based on Screening medical history, physical examination, vital signs, and clinical laboratory values.
  • Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
  • For women of reproductive potential: has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
  • For women of reproductive potential and men with female partners of reproductive potential: agrees to remain abstinent from sexual intercourse or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug.

Key Exclusion Criteria:

  • Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
  • Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
  • Fails to discontinue prohibited psychotropic medications.
  • Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
  • Is currently hospitalized involuntarily or incarcerated.
  • Has a history or presence of any clinically significant medical condition, disease, or surgical history that could, in the investigator's opinion, jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug.
  • Is, in the investigator's opinion, not a suitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SP-624
SP-624 oral capsule, 20 mg once daily
Drug: SP-624
Oral Capsule
PLACEBO_COMPARATOR: Placebo
Placebo oral capsule, once daily
Drug: Placebo
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 8 weeks
Up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Abnormal Clinical Laboratory Values
Time Frame: Up to 4 weeks
chemistry, hematology, and urinalysis tests will be performed
Up to 4 weeks
Change from Baseline in Blood Pressure (mmHg)
Time Frame: Up to 4 weeks
Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated
Up to 4 weeks
Change from Baseline in Pulse Rate (beats per minute)
Time Frame: Up to 4 weeks
Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated
Up to 4 weeks
Change from Baseline in Body Temperature (degrees celsius)
Time Frame: Up to 4 weeks
Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated
Up to 4 weeks
Change from Baseline in Body Weight (kilograms)
Time Frame: Up to 4 weeks
Body weight is measured by weight scale. Measurement is reported in kilograms. Change from Baseline measurement will be calculated.
Up to 4 weeks
Change from Baseline in ECG Heart Rate (beats per minute)
Time Frame: Up to 4 weeks
Heart rate is measured by 12-lead electrocardiogram (ECG). Change from Baseline measure will be calculated.
Up to 4 weeks
Change from Baseline in ECG RR Interval (seconds)
Time Frame: Up to 4 weeks
RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Up to 4 weeks
Change from Baseline in ECG PR Interval (milliseconds)
Time Frame: Up to 4 weeks
PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Up to 4 weeks
Change from Baseline in ECG QTcF Interval (milliseconds)
Time Frame: Up to 4 weeks
QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Up to 4 weeks
Number of Participants with Abnormal Physical Examination Findings
Time Frame: Up to 4 weeks
Up to 4 weeks
Number of Participants with treatment-emergent suicidal ideation or behavior
Time Frame: Up to 5 weeks
Treatment-emergent suicidal ideation and/or behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Up to 5 weeks
Number of Participants with treatment-emergent abnormal movements
Time Frame: Up to 4 weeks
Treatment-emergent abnormal movements will be assessed using a battery of movement assessments
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sirtsei Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-624-221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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