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

Primary Purpose

Cognitive Impairment, Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RL-007

RL-007 Matching Placebo

About this trial

This is an interventional treatment trial for Cognitive Impairment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Collaborative Neuroscience Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose-escalation - RL-007

Dose-escalation - matching Placebo

Arm Description

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.

Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.

Outcomes

Primary Outcome Measures

Incidence of Treatment-emergent Adverse Events (TEAE)

Comparison of AE rates between active and placebo dosing

Change in blood pressure (systolic and diastolic) from baseline

blood pressure measured in mmHg; baseline = Day -1

Change in heart rate from baseline

heart rate measured in beats per minute; baseline = Day -1

Change in respiratory rate from baseline

respiratory rate measured in breaths per minute; baseline = Day -1

Change in temperature from baseline

temperature measured in degrees Celsius; baseline = Day -1

Change in electrocardiogram (ECG) from baseline

overall physician interpretation of ECG reading; baseline = Day -1

Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline

The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1

Secondary Outcome Measures

Change from baseline in quantitative electroencephalogram (qEEG)

change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)

Change from baseline in evoked response potential (ERP) amplitude

Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP

Change from baseline in evoked response potential (ERP) latency

Change from baseline in signal latency of the two-stimulus auditory oddball ERP

Change from baseline in amplitude of mismatch negativity (MMN) ERP

Change from baseline in signal amplitude of the MMN ERP

Change from baseline in latency of mismatch negativity (MMN) ERP

Change from baseline in signal latency of the MMN ERP

Full Information

NCT ID

NCT04822883

First Posted

March 12, 2021

Last Updated

April 25, 2022

Sponsor

Recognify Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04822883

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 26, 2021 (Actual)

Primary Completion Date

October 28, 2021 (Actual)

Study Completion Date

October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Recognify Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment, Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Four dose cohorts will be enrolled sequentially.

Masking

Participant

Masking Description

Participants will not be informed of their dose cohort or of the sequence of placebo or active capsules.

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose-escalation - RL-007

Arm Type

Experimental

Arm Description

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.

Arm Title

Dose-escalation - matching Placebo

Arm Type

Placebo Comparator

Arm Description

Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.

Intervention Type

Drug

Intervention Name(s)

RL-007

Intervention Description

Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing

Intervention Type

Drug

Intervention Name(s)

RL-007 Matching Placebo

Intervention Description

Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing

Primary Outcome Measure Information:

Title

Incidence of Treatment-emergent Adverse Events (TEAE)

Description

Comparison of AE rates between active and placebo dosing

Time Frame

Study Day 8.

Title

Change in blood pressure (systolic and diastolic) from baseline

Description

blood pressure measured in mmHg; baseline = Day -1

Time Frame

Study Day 4

Title

Change in heart rate from baseline

Description

heart rate measured in beats per minute; baseline = Day -1

Time Frame

Study Day 4

Title

Change in respiratory rate from baseline

Description

respiratory rate measured in breaths per minute; baseline = Day -1

Time Frame

Study Day 4

Title

Change in temperature from baseline

Description

temperature measured in degrees Celsius; baseline = Day -1

Time Frame

Study Day 4

Title

Change in electrocardiogram (ECG) from baseline

Description

overall physician interpretation of ECG reading; baseline = Day -1

Time Frame

Study Day 3

Title

Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline

Description

The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1

Time Frame

Study Day 8

Secondary Outcome Measure Information:

Title

Change from baseline in quantitative electroencephalogram (qEEG)

Description

change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)

Time Frame

Study Day 4

Title

Change from baseline in evoked response potential (ERP) amplitude

Description

Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP

Time Frame

Study Day 4

Title

Change from baseline in evoked response potential (ERP) latency

Description

Change from baseline in signal latency of the two-stimulus auditory oddball ERP

Time Frame

Study Day 4

Title

Change from baseline in amplitude of mismatch negativity (MMN) ERP

Description

Change from baseline in signal amplitude of the MMN ERP

Time Frame

Study Day 4

Title

Change from baseline in latency of mismatch negativity (MMN) ERP

Description

Change from baseline in signal latency of the MMN ERP

Time Frame

Study Day 4

Other Pre-specified Outcome Measures:

Title

Verbal learning performance

Description

Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R)

Time Frame

Study Day 4

Title

Symbol coding performance

Description

Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test

Time Frame

Study Day 4

Title

Category fluency performance

Description

Number of appropriate items provided in the Category Fluency Task

Time Frame

Study Day 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Walling, PhD

Organizational Affiliation

Collaborative Neuroscience Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Collaborative Neuroscience Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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