Trials / Completed
CompletedNCT05686239
A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
An Adaptive, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Recognify Life Sciences · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia. The main questions the study aims to answer are: 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.
Detailed description
This is a randomized, 3-arm, placebo-controlled, double-blinded clinical trial to evaluate the efficacy, safety, and tolerability of RL-007 in subjects with stable schizophrenia. The treatment period is 6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RL-007 (Inidascamine) | investigational study drug |
| DRUG | Placebo | placebo capsules matching the appearance and size of the active drug |
Timeline
- Start date
- 2022-12-08
- Primary completion
- 2025-04-09
- Completion
- 2025-04-09
- First posted
- 2023-01-17
- Last updated
- 2025-07-30
Locations
36 sites across 4 countries: United States, Bulgaria, Czechia, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05686239. Inclusion in this directory is not an endorsement.