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

• ClinicalTrials.gov Identifier: NCT04822883
• Recruitment Status: Recruiting
• First Posted: March 30, 2021
• Last Update Posted: September 21, 2021
• Sponsor: Recognify Life Sciences
• Information provided by (Responsible Party): Recognify Life Sciences

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

Condition or disease	Intervention/treatment	Phase
Cognitive Impairment; Schizophrenia	Drug: RL-007; Drug: RL-007 Matching Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Four dose cohorts will be enrolled sequentially.
• Masking: Single (Participant)
• Masking Description: Participants will not be informed of their dose cohort or of the sequence of placebo or active capsules.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 26, 2021
• Estimated Primary Completion Date: October 15, 2021
• Estimated Study Completion Date: October 30, 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment-emergent Adverse Events (TEAE) [ Time Frame: Study Day 8. ]
   Comparison of AE rates between active and placebo dosing
2. Change in blood pressure (systolic and diastolic) from baseline [ Time Frame: Study Day 4 ]
   blood pressure measured in mmHg; baseline = Day -1
3. Change in heart rate from baseline [ Time Frame: Study Day 4 ]
   heart rate measured in beats per minute; baseline = Day -1
4. Change in respiratory rate from baseline [ Time Frame: Study Day 4 ]
   respiratory rate measured in breaths per minute; baseline = Day -1
5. Change in temperature from baseline [ Time Frame: Study Day 4 ]
   temperature measured in degrees Celsius; baseline = Day -1
6. Change in electrocardiogram (ECG) from baseline [ Time Frame: Study Day 3 ]
   overall physician interpretation of ECG reading; baseline = Day -1
7. 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

Secondary Outcome Measures :

1. 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)
2. 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
3. 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
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
5. 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

Other Outcome Measures:

1. Verbal learning performance [ Time Frame: Study Day 4 ]
   Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R)
2. Symbol coding performance [ Time Frame: Study Day 4 ]
   Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test
3. Category fluency performance [ Time Frame: Study Day 4 ]
   Number of appropriate items provided in the Category Fluency Task

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Study Manager; 510-552-0136; gary.walker@recognify.life

Locations

United States, California

Collaborative Neuroscience Research; Recruiting

Long Beach, California, United States, 90806

Contact: CEO 714-799-7799

Principal Investigator: David Walling, PhD

Sponsors and Collaborators

Recognify Life Sciences

Investigators

• Principal Investigator: David Walling, PhD; Collaborative Neuroscience Research

More Information

• Responsible Party: Recognify Life Sciences
• ClinicalTrials.gov Identifier: NCT04822883
• Other Study ID Numbers: C07-03-01
• First Posted: March 30, 2021
• Last Update Posted: September 21, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders