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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-emergent Adverse Events (TEAE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will not be informed of their dose cohort or of the sequence of placebo or active capsules.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, G
- •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
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.
Arms & Interventions
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.
Intervention: RL-007 (Drug)
Dose-escalation - matching Placebo
Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.
Intervention: RL-007 Matching Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-emergent Adverse Events (TEAE)
Time Frame: Study Day 8.
Comparison of AE rates between active and placebo dosing
Change in heart rate from baseline
Time Frame: Study Day 4
heart rate measured in beats per minute; baseline = Day -1
Change in respiratory rate from baseline
Time Frame: Study Day 4
respiratory rate measured in breaths per minute; baseline = Day -1
Change in temperature from baseline
Time Frame: Study Day 4
temperature measured in degrees Celsius; baseline = Day -1
Change in electrocardiogram (ECG) from baseline
Time Frame: Study Day 3
overall physician interpretation of ECG reading; baseline = Day -1
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
Change in blood pressure (systolic and diastolic) from baseline
Time Frame: Study Day 4
blood pressure measured in mmHg; baseline = Day -1
Secondary Outcomes
- 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)