Clinical TrialSchizophreniaPlaceboCompleted

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

Interventional, sequential Phase II dose-escalation study (n=37) assessing safety and EEG biomarkers of RL-007 (cohorts 10–80 mg, TID) with within-cohort placebo sequences in adults with schizophrenia.

Target Enrollment
37 participants
Study Type
Phase II interventional
Design
Non-randomized, single Blind

Detailed Description

Sequential, non-randomised, single-blind Phase II trial enrolling four dose cohorts (10, 20, 40, 80 mg) to evaluate safety and effects of RL-007 on brain electrical activity and cognition in patients with schizophrenia.

Participants are admitted as in-patients for 5 days/4 nights; within each cohort participants receive sequences of active and matching placebo capsules (TID); assessments include EEG/ERP and cognitive testing on study days 2 and 4.

Study Arms & Interventions

RL-007

experimental

Dose-escalation cohorts of RL-007; within-cohort sequences include active and matching placebo.

Interventions

  • Compound10 - 80 mg
    via Oral• TID

    Cohorts: 10, 20, 40, 80 mg; TID dosing; sequence includes active and placebo within cohort.

Placebo

inactive

Matching placebo capsules; sequence varied within cohort and unknown to participant.

Interventions

  • Placebo
    via Oral• TID

    Matching placebo capsules

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion 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

Exclusion Criteria

  • 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 Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomizedsingle Blind
  • Target Enrollment37 participants
  • Timeline
    Start: 2021-04-26
    End: 2021-10-28
  • Compound
    Placebo
  • Topic
    Schizophrenia

Locations

Collaborative Neuroscience Research — Long Beach, California, United States

Your Library