Dravet Syndrome Treatment with Lorcaserin – Phase III

Study with Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects with Dravet Syndrome

Protocol Description

The purpose of this study is to assess the effectiveness and side effects of the drug lorcaserin for people who have Dravet syndrome, a rare form of epilepsy that develops in infancy and causes convulsive seizures.

Study Level: Phase III

Eligibility Criteria

Subject to certain inclusion and exclusion criteria, this study is enrolling participants who are at least 2 years of age and who have been diagnosed with epilepsy with Dravet syndrome.
Males and Females: Ages 2 and older


Following a four-week screening period, participants will be randomly assigned to a group that will take either lorcaserin or a placebo over a period of 14 weeks. Upon completion of this core phase, participants may participate in a 12-week extension period in which all participants will receive the study drug. From screening through treatment phases and final follow-up, participants will be seen by the study team at regular visits for physical examinations and medical testing. After the extension phase, participants may also be able to join an extended-access program to continue taking lorcaserin.
Visits: 14
Duration: 34 weeks

Status: Open to Enrollment

Source(s) of Support


Primary Investigator

Yoshimi Sogawa, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinator Dawn Thomas RN, MSN, CPN
412-692-5142 or 412-864-7442