NCT05364021CompletedPhase 1/2
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, PK, PD, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 22 Mar 2022
- Start date
- 3 Mar 2022
- Primary completion date
- 16 Nov 2023
- Lead sponsor
- Longboard Pharmaceuticals
- Diseases
- Epilepsy
- NCT number
- NCT05364021
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 52
- From 3 Mar 2022 to the primary completion date, 16 Nov 2023
- 34 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
- Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
Other illness
- Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
- Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
- Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
Who the study is looking for
- Male or non-pregnant, non-lactating female, age 12 to 65 years
- Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
- Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
- All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
- The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed
Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Children's Hospital, Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Royal Brisbane & Women s Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Child Neurology Consultants of Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Epilepsy Care Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Mid-Atlantic Epilepsy and Sleep Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Consultants in Epilepsy and Neurology Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Onsite Clinical Solutions, LLC Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Northwestern University Feinberg School of Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Rancho Los Amigos National Rehabilitation Center (RLANRC) Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| Spectrum Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Northwest Florida Clinical Research Group Coordinator of this site? Confirm its status | Gulf Breeze | United States | Unknown status |
| Boston Children's Health Physicians LLP Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
| Hawaii Pacific Neuroscience Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| New York University Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Advent Health Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Research Institute of Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Providence Neurological Specialties-East Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Washington Valley Medical Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Northeast Regional Epilepsy Group Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| University of Arizona Health Sciences Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Wake Forest University School of Medicine Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.