A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

Summary

The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.

Timeline

Start

2020-09-23

Primary completion

2024-08-15

Completion

2024-08-15

Outcome

Met primary endpoint

Stopped: “The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.”

registry analysis (superiority test); Core Study: Placebo vs Core Study: Lorcaserin; Median Difference (Final Values) -86.08 (95% CI -144.01 to -28.14) NCT04572243 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorcaserin	Small molecule	5 mg	Oral
Subject	Lorcaserin	Small molecule	10 mg	Oral
Subject	Lorcaserin	Small molecule	20 mg	Oral

Indications