NCT05678881

Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy

A Phase 1b Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (Inhaled Dry Powder Cannabidiol [CBD]) in a Clinical Model of Photosensitive Epilepsy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Receptor Life Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.

Detailed description

Approximately 5 subjects with a known stable photoparoxysmal response (PPR) on EEG, will be administered high dose RLS103 and placebo in a blinded, randomized, crossover design. Patient EEG responses will be compared between RLS103 and placebo. An additional low dose RLS103 may be administered to each patient in an open label period. On study days, several procedures and intermittent photic stimulation (IPS) assessments will be performed at pre-determined times over the course of the day. After the subject completes both treatment visits, the blinded IPS data will be reviewed and analyzed by the Sponsor and the Epilepsy Study Consortium, Inc. If the blinded data on the 2 treatment days indicates a differential response, a decision will be made whether the subject will be asked to continue in the open label phase. The open label phase will consist of one visit, lasting 1 day.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	High dose RLS103	8 mg CBD inhaled powder
DRUG	placebo inhaled powder	placebo inhaled powder
DRUG	Low dose RLS103	4 mg CBD inhaled powder (open label)

Timeline

• Start date: 2022-04-25
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2023-01-10
• Last updated: 2024-05-02

Regulatory

• FDA-regulated drug study