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

NCT04822883 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: C07-03-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Impairment; Schizophrenia

Outcome Measures

Primary Outcomes (7)

• Incidence of Treatment-emergent Adverse Events (TEAE)

  Comparison of AE rates between active and placebo dosing

  Study Day 8.

• Change in blood pressure (systolic and diastolic) from baseline

  blood pressure measured in mmHg; baseline = Day -1

  Study Day 4

• Change in heart rate from baseline

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

  Study Day 4

• Change in respiratory rate from baseline

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

  Study Day 4

• Change in temperature from baseline

  temperature measured in degrees Celsius; baseline = Day -1

  Study Day 4

• Change in electrocardiogram (ECG) from baseline

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

  Study Day 3

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

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

  Study Day 8

Secondary Outcomes (5)

• Change from baseline in quantitative electroencephalogram (qEEG)

  Study Day 4

• Change from baseline in evoked response potential (ERP) amplitude

  Study Day 4

• Change from baseline in evoked response potential (ERP) latency

  Study Day 4

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

  Study Day 4

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

  Study Day 4

Other Outcomes (3)

• Verbal learning performance

  Study Day 4

• Symbol coding performance

  Study Day 4

• Category fluency performance

  Study Day 4

Study Arms (2)

Dose-escalation - RL-007

EXPERIMENTAL

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

Dose-escalation - matching Placebo

PLACEBO COMPARATOR

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

Interventions

RL-007 DRUG

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

Dose-escalation - RL-007

RL-007 Matching Placebo DRUG

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

Dose-escalation - matching Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recognify Life Sciences: lead

Study Sites (1)

Collaborative Neuroscience Research

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Schizophrenia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• David Walling, PhD

  Collaborative Neuroscience Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed of their dose cohort or of the sequence of placebo or active capsules.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Four dose cohorts will be enrolled sequentially.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 30, 2021
• Study Start: April 26, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)