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

Recognify Life Sciences

Status and phase: Completed; Phase 2

Conditions: Cognitive Impairment; Schizophrenia

Treatments: Drug: RL-007; Drug: RL-007 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04822883

C07-03-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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37 participants in 2 patient groups, including a placebo group

Dose-escalation - RL-007

Experimental group

Description:

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.

Treatment:

Drug: RL-007

Dose-escalation - matching Placebo

Placebo Comparator group

Description:

Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.

Treatment:

Drug: RL-007 Matching Placebo