Intermediate-Size Expanded Access Protocol (EAP) for LP352

Dravet Syndrome Clinical Trial

Official title:

Expanded Access Treatment With LP352 for Patients With Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT06149663
• Other study ID #: LP352-EAP-01
• Status: Available

Study information

• Verified date: February 2024
• Source: Longboard Pharmaceuticals
• Contact: Longboard Study Contact
• Phone: 858-999-8858
• Email: clinicalstudies[@]longboardpharma.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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 patients with Developmental and Epileptic Encephalopathies (DEEs). The EAP study will allow continued treatment with LP352 for eligible patients diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation).

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patient and/or patient'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. Patient with DEE who has successfully completed an LP352 Clinical Trial.

3. Patient currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.

4. Patient currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

Exclusion Criteria:

1. Patient 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.

Related Conditions & MeSH terms

• Brain Diseases
• Dravet Syndrome
• Epilepsies, Myoclonic
• Epilepsy
• Lennox Gastaut Syndrome
• Syndrome

Intervention

Drug:
• LP352
LP352 will be administered as a liquid either orally or through a G-tube or PEG tube.

Locations

Country	Name	City	State
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Northwest Florida Clinical Research Group	Gulf Breeze	Florida
United States	Research Institute of Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Longboard Pharmaceuticals

Country where clinical trial is conducted

United States,