Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

April 25, 2022 updated by: Recognify Life Sciences

A Single-arm, Single-blind, Multiple Dose Study to Evaluate Safety and the Effects of RL-007 on Electroencephalograms and Event-related Potentials in Subjects With Schizophrenia

The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia

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.

Detailed Description

Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.

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.
37

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 2

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
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Research

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Provide a written informed consent
  • Diagnosis of schizophrenia, as defined by DSM-5 and evaluated with the MINI Plus interview
  • Positive and Negative Symptoms Severity Score (PANSS) of 40 - 80 (inclusive), and a score of 4 or less on the following PANSS items: P2, P3, P5, P6, G6.
  • Currently being treated with a single protocol-allowed antipsychotic at a stable dose and clinically stable for at least 8 weeks before admission (note: allowed meds = aripiprazole, brexipiprazole, paliperidone, risperidone)
  • Modified Simpson-Angus Scale total score <= 4
  • At least 1 standard deviation below normative value of total number of words recalled on the Hopkins Verbal Learning Test
  • BMI <= 38

Key Exclusion Criteria:

  • History of hospitalization for medical indication within 4 weeks prior to screening or psychiatric hospitalization within 3 months prior to screening
  • Use of any other psychoactive medication known to interfere with the EEG/ERP assessments within 1 week prior to screening or during the study period.
  • Subjects who present a serious risk of suicide
  • Any history of GI surgery, or other condition, that may affect GI absorption or any history of GI bleeding or peptic ulcer.
  • Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator would confound secondary or exploratory assessments or prevent safe and satisfactory completion of the study protocol.
  • Moderate to severe alcohol use disorder, per DSM-5 within 3 months of admission visit.
  • Positive alcohol breath test or urine test for drugs of abuse at either screening or admission visit.
  • Currently smoking more than 1 pack of cigarettes a day and unable or unwilling to maintain smoking to less than 1 pack a day during in-patient portion of study.
  • Positive test result for SARS-CoV2 prior to admission per site standards.
  • Positive test for hepatitis B, hepatitis C or HIV
  • Subjects whose hair type or style is likely to interfere with successful application of scalp electrodes.
  • Subjects with needle phobia or in whom venous access is technically difficult.
  • Other unspecified reasons that, in the opinion of the PI or sponsor, make the subject unsuitable for enrollment.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

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: Dose-escalation - RL-007
Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.
Drug: RL-007
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
Placebo Comparator: Dose-escalation - matching Placebo
Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.
Drug: RL-007 Matching Placebo
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing

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
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events (TEAE)
Time Frame: Study Day 8.
Comparison of AE rates between active and placebo dosing
Study Day 8.
Change in blood pressure (systolic and diastolic) from baseline
Time Frame: Study Day 4
blood pressure measured in mmHg; baseline = Day -1
Study Day 4
Change in heart rate from baseline
Time Frame: Study Day 4
heart rate measured in beats per minute; baseline = Day -1
Study Day 4
Change in respiratory rate from baseline
Time Frame: Study Day 4
respiratory rate measured in breaths per minute; baseline = Day -1
Study Day 4
Change in temperature from baseline
Time Frame: Study Day 4
temperature measured in degrees Celsius; baseline = Day -1
Study Day 4
Change in electrocardiogram (ECG) from baseline
Time Frame: Study Day 3
overall physician interpretation of ECG reading; baseline = Day -1
Study Day 3
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline
Time Frame: Study Day 8
The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
Study Day 8

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
Change from baseline in quantitative electroencephalogram (qEEG)
Time Frame: Study Day 4
change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)
Study Day 4
Change from baseline in evoked response potential (ERP) amplitude
Time Frame: Study Day 4
Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
Study Day 4
Change from baseline in evoked response potential (ERP) latency
Time Frame: Study Day 4
Change from baseline in signal latency of the two-stimulus auditory oddball ERP
Study Day 4
Change from baseline in amplitude of mismatch negativity (MMN) ERP
Time Frame: Study Day 4
Change from baseline in signal amplitude of the MMN ERP
Study Day 4
Change from baseline in latency of mismatch negativity (MMN) ERP
Time Frame: Study Day 4
Change from baseline in signal latency of the MMN ERP
Study Day 4

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Verbal learning performance
Time Frame: Study Day 4
Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R)
Study Day 4
Symbol coding performance
Time Frame: Study Day 4
Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test
Study Day 4
Category fluency performance
Time Frame: Study Day 4
Number of appropriate items provided in the Category Fluency Task
Study Day 4

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.
Recognify Life Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Walling, PhD, Collaborative Neuroscience Research

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.
April 26, 2021

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.
October 28, 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.
October 28, 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).
March 12, 2021

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.
March 26, 2021

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.
March 30, 2021

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 27, 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 25, 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.
  • C07-03-01

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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