A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
NCT ID: NCT05686239
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2022-12-08
2025-04-09
Brief Summary
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1. Does RL-007 improve subjects performance in a set of cognitive tasks?
2. Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance?
3. How well do subjects tolerate RL-007?
In the study, subjects will perform the cognitive tasks at the beginning to get familiar with the tasks. Then, subjects will be given either RL-007 or a placebo for 6 weeks and then repeat the cognitive tasks. The researchers will compare the results at the end of the treatment period to the baseline to see if there have been any changes in performance.
Additionally, several safety measures will be collected throughout the study (blood pressure, physical exam, ECGs, etc) to evaluate if there are any side effects from taking RL-007.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RL-007 20 mg (Inidascamine)
oral dosing three times per day (TID)
RL-007 (Inidascamine)
investigational study drug
RL-007 40 mg (Inidascamine)
oral dosing three times per day (TID)
RL-007 (Inidascamine)
investigational study drug
Placebo
oral dosing three times per day (TID)
Placebo
placebo capsules matching the appearance and size of the active drug
Interventions
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RL-007 (Inidascamine)
investigational study drug
Placebo
placebo capsules matching the appearance and size of the active drug
Eligibility Criteria
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Inclusion Criteria
* Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive)
* Currently treated on a single atypical antipsychotic (other than clozapine) at a stable dose and clinically stable for at least 6 weeks before randomization
* Clinical Global Impression - Severity score \< 5.
* Body mass index (BMI) \<= 40.0 kg/m\^2 at screening
* Participant has reliable housing that is not expected to change during the study period with no expected significant life events that could affect study outcomes throughout entire study period.
* Sufficient fluency in English to understand and complete study instructions and assessments
Exclusion Criteria
* Participants who present a serious risk of suicide, as evidenced by a) "yes" on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) and meeting these criteria within the past 6 months, or b) posing a significant suicide risk in the Investigator's judgement.
* Participants who present a risk of serious harm to others, as evidence by any history within the past 2 years and any expressed homicidal ideation (with or without plan).
* Current diagnosis of another major psychiatric disorder, intellectual disability, or any major neurological disease, brain injury, epilepsy, or severe brain trauma.
* Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator or Sponsor would confound interpretation of study data or prevent safe and satisfactory completion of the study protocol.
* Meets criteria for moderate to severe substance/drug abuse disorder (including alcohol) per DSM-5 within the last 6 months prior to informed consent or a positive alcohol breath test or urine test for drugs of abuse at either Screening or Randomization Visits (except for benzodiazepines taken according to prescription and as an ongoing, stable regimen).
* Participant has undergone electroconvulsive therapy within the past 12 months.
18 Years
55 Years
ALL
No
Sponsors
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INDUSTRY
Responsible Party
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Principal Investigators
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Gary Walker, PhD
Role: STUDY_DIRECTOR
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Locations
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Culver City, California, United States
Collaborative Neuroscience Research
Garden Grove, California, United States
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Lafayette, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Torrance, California, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Gaithersburg, Maryland, United States
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Berlin, New Jersey, United States
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Brooklyn, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Everett, Washington, United States
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Burgas, , Bulgaria
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Kardzhali, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Varna, , Bulgaria
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Gdansk, , Poland
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Gorlice, , Poland
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Kielce, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
Countries
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Other Identifiers
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C07-03-02
Identifier Type: -
Identifier Source: org_study_id
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