- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822883
Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia
April 25, 2022 updated by: Recognify Life Sciences
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Long Beach, California, United States, 90806
- Collaborative Neuroscience Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
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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.
|
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-emergent Adverse Events (TEAE)
Time Frame: Study Day 8.
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Comparison of AE rates between active and placebo dosing
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Study Day 8.
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Change in blood pressure (systolic and diastolic) from baseline
Time Frame: Study Day 4
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blood pressure measured in mmHg; baseline = Day -1
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Study Day 4
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Change in heart rate from baseline
Time Frame: Study Day 4
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heart rate measured in beats per minute; baseline = Day -1
|
Study Day 4
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Change in respiratory rate from baseline
Time Frame: Study Day 4
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respiratory rate measured in breaths per minute; baseline = Day -1
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Study Day 4
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Change in temperature from baseline
Time Frame: Study Day 4
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temperature measured in degrees Celsius; baseline = Day -1
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Study Day 4
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Change in electrocardiogram (ECG) from baseline
Time Frame: Study Day 3
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overall physician interpretation of ECG reading; baseline = Day -1
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Study Day 3
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Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline
Time Frame: Study Day 8
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The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
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Study Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in quantitative electroencephalogram (qEEG)
Time Frame: Study Day 4
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change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)
|
Study Day 4
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Change from baseline in evoked response potential (ERP) amplitude
Time Frame: Study Day 4
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Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
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Study Day 4
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Change from baseline in evoked response potential (ERP) latency
Time Frame: Study Day 4
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Change from baseline in signal latency of the two-stimulus auditory oddball ERP
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Study Day 4
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Change from baseline in amplitude of mismatch negativity (MMN) ERP
Time Frame: Study Day 4
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Change from baseline in signal amplitude of the MMN ERP
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Study Day 4
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Change from baseline in latency of mismatch negativity (MMN) ERP
Time Frame: Study Day 4
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Change from baseline in signal latency of the MMN ERP
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Study Day 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal learning performance
Time Frame: Study Day 4
|
Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R)
|
Study Day 4
|
Symbol coding performance
Time Frame: Study Day 4
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Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test
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Study Day 4
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Category fluency performance
Time Frame: Study Day 4
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Number of appropriate items provided in the Category Fluency Task
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Study Day 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Walling, PhD, Collaborative Neuroscience Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2021
Primary Completion (Actual)
October 28, 2021
Study Completion (Actual)
October 28, 2021
Study Registration Dates
First Submitted
March 12, 2021
First Submitted That Met QC Criteria
March 26, 2021
First Posted (Actual)
March 30, 2021
Study Record Updates
Last Update Posted (Actual)
April 27, 2022
Last Update Submitted That Met QC Criteria
April 25, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C07-03-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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