Developmental and Epileptic Encephalopathies, Dravet Syndrome, Lennox Gastaut Syndrome
Conditions
Keywords
CDKL5 deficiency disorder, developmental and epileptic encephalopathy, Dravet Syndrome, epilepsy, Lennox Gastaut Syndrome, treatment resistant epilepsy, tuberous sclerosis complex
Brief summary
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.
Interventions
DRUGLP352
LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous Endoscopic Gastrotomy (PEG) tube.
Sponsors
Longboard Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Inclusion criteria
1. Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (\<18 years of age) as required by local regulations. 2. Participant with DEE who has successfully completed an LP352 Clinical Trial. 3. Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician. 4. Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.
Exclusion criteria
1. Participant was discontinued from an LP352 Clinical Trial for any reason. 2. Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.
Countries
Australia, United States
Contacts
Primary ContactLongboard Study Contact
Outcome results
None listed