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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822883
• Other study ID #: C07-03-01
• Status: Completed
• Phase: Phase 2
• Start date: April 26, 2021
• Est. completion date: October 28, 2021

Study information

• Verified date: April 2022
• Source: Recognify Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Schizophrenia

Intervention

Drug:
• RL-007
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
• RL-007 Matching Placebo
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Research	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Recognify Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Verbal learning performance	Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R)	Study Day 4
Other	Symbol coding performance	Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test	Study Day 4
Other	Category fluency performance	Number of appropriate items provided in the Category Fluency Task	Study Day 4
Primary	Incidence of Treatment-emergent Adverse Events (TEAE)	Comparison of AE rates between active and placebo dosing	Study Day 8.
Primary	Change in blood pressure (systolic and diastolic) from baseline	blood pressure measured in mmHg; baseline = Day -1	Study Day 4
Primary	Change in heart rate from baseline	heart rate measured in beats per minute; baseline = Day -1	Study Day 4
Primary	Change in respiratory rate from baseline	respiratory rate measured in breaths per minute; baseline = Day -1	Study Day 4
Primary	Change in temperature from baseline	temperature measured in degrees Celsius; baseline = Day -1	Study Day 4
Primary	Change in electrocardiogram (ECG) from baseline	overall physician interpretation of ECG reading; baseline = Day -1	Study Day 3
Primary	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	Change from baseline in quantitative electroencephalogram (qEEG)	change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)	Study Day 4
Secondary	Change from baseline in evoked response potential (ERP) amplitude	Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP	Study Day 4
Secondary	Change from baseline in evoked response potential (ERP) latency	Change from baseline in signal latency of the two-stimulus auditory oddball ERP	Study Day 4
Secondary	Change from baseline in amplitude of mismatch negativity (MMN) ERP	Change from baseline in signal amplitude of the MMN ERP	Study Day 4
Secondary	Change from baseline in latency of mismatch negativity (MMN) ERP	Change from baseline in signal latency of the MMN ERP	Study Day 4