A Multicenter Double-Blind Randomized Placebo-Controlled Parallel Group Study with Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects with Dravet Syndrome | NYU Langone Health

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A Multicenter Double-Blind Randomized Placebo-Controlled Parallel Group Study with Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects with Dravet Syndrome

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Dravet Syndrome
Age: Between 2 years - 99 years
Gender: Male or Female

Other Inclusion Criteria:
1. Male or female, age =2 years at the time of informed consent (or assent)
2. Confirmed diagnosis of epilepsy with Dravet syndrome
3. Has had at least 4 convulsive seizures during the 4 weeks of the Prerandomization Phase
4. Currently treated with at least 1 AED and the doses of all AEDs must be stable for at least 4 weeks before Screening
5. If vagal nerve stimulator, responsive neurostimulator, or deep brain stimulator is used, it must be implanted at least 5 months before Screening and be expected to remain stable throughout the study
6. If a ketogenic diet is followed, it must be stable for at least 4 weeks before Screening and be expected to remain stable throughout the study

You may not be eligible for this study if the following are true:

1. Breastfeeding or pregnant
2. Use of lorcaserin within 4 weeks before Screening
3. Use of serotonergic or other prohibited drugs administered within 7 days
4. Has a history of status epilepticus that required hospitalization during the 6 months before Screening
5. Currently has progressive central nervous system disease, other than Dravet syndrome, including degenerative central nervous system diseases and progressive tumors
6. Any history of malignancies
7. Evidence of clinically significant disease that in the opinion of the investigator could affect the subject’s safety or interfere with the study assessments
8. Any history of or concomitant medical condition that in the opinion of the investigator would compromise the subject’s ability to safely complete the study
9. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening
10. Any lifetime suicidal behavior
11. Hypersensitivity to the study drug and any of the excipients
12. Scheduled for surgery during the study
13. Use of illegal recreational drugs
14. Currently enrolled in another clinical study or used any investigational drug or device