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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05364021
Registration number
NCT05364021
Ethics application status
Date submitted
22/03/2022
Date registered
6/05/2022
Date last updated
19/01/2024
Titles & IDs
Public title
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
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Scientific title
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
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Secondary ID [1]
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LP352-201
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Universal Trial Number (UTN)
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Trial acronym
PACIFIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Developmental and Epileptic Encephalopathy
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Dravet Syndrome
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Lennox Gastaut Syndrome
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Condition category
Condition code
Neurological
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Epilepsy
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LP352
Treatment: Drugs - Placebo
Experimental: LP352 - Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 60-day maintenance period and a 15-day taper/down titration period.
Placebo Comparator: Placebo - Placebo for LP352
Treatment: Drugs: LP352
LP352 administered three times daily, orally or through G-tube
Treatment: Drugs: Placebo
Matching placebo for LP352 administered three times daily, orally or through G-tube
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment-emergent Adverse Events
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Assessment method [1]
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Incidence and severity of adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
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Timepoint [1]
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Baseline up to Day 75
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Primary outcome [2]
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Columbia-Suicide Severity Rating Scale (C-SSRS) Response
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Assessment method [2]
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Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
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Timepoint [2]
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Baseline up to Day 75
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Primary outcome [3]
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Patient Health Questionnaire-9 Total Score and Question 9 Score
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Assessment method [3]
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Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder
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Timepoint [3]
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Baseline up to Day 75
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Primary outcome [4]
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Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period
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Assessment method [4]
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Timepoint [4]
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Baseline up to Day 75
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Primary outcome [5]
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Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period
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Assessment method [5]
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Timepoint [5]
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Baseline up to Day 75
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Secondary outcome [1]
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Observed Plasma Concentrations of LP352 by Time and Dose
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Assessment method [1]
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Timepoint [1]
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Baseline up to Day 75
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Secondary outcome [2]
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Modeled Estimate of Average Plasma Concentration
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Assessment method [2]
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Timepoint [2]
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Baseline up to Day 75
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Secondary outcome [3]
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Modeled Estimate of Observed Plasma Concentration Just Prior to Dosing
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Assessment method [3]
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Timepoint [3]
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Baseline up to Day 75
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Secondary outcome [4]
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Correlation of Plasma Concentration with Incidence of Treatment-emergent Adverse Events
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Assessment method [4]
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Timepoint [4]
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Baseline up to Day 75
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Secondary outcome [5]
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Correlation of Plasma Concentration with Seizure Frequency
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Assessment method [5]
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Timepoint [5]
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Baseline up to Day 75
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Secondary outcome [6]
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Observed and Change from Baseline Prolactin Concentration During the Treatment Period
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Assessment method [6]
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Timepoint [6]
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Baseline up to Day 75
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Eligibility
Key inclusion criteria
Key
1. Male or non-pregnant, non-lactating female, age 12 to 65 years
2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and
epileptic encephalopathy
3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure
medications
4. All medications and epilepsy interventions must be stable for 4 weeks before screening
and are expected to remain stable during the study
5. The patient/parent/caregiver is able and willing to attend study visits, complete the
diary and take study drug as instructed
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Minimum age
12
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac
valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or
abnormal blood pressure
2. Has glaucoma, renal impairment, liver disease or any other medical condition that
would affect study participation or pose a risk to the subject
3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia
or at risk of suicidal behavior
4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or
antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications
for weight loss
5. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for
patients taking prescribed cannabidiol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/11/2023
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane Women's Hospital - Herston
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Recruitment hospital [2]
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [3]
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Monash Children's Hospital, Monash Health - Clayton
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Recruitment hospital [4]
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Austin Health - Heidelberg
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Recruitment hospital [5]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Arkansas
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United States of America
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California
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United States of America
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Florida
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Country [5]
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United States of America
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State/province [5]
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Hawaii
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Country [6]
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United States of America
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Idaho
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United States of America
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Illinois
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Country [8]
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United States of America
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State/province [8]
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Maryland
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Country [9]
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United States of America
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Michigan
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Minnesota
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Missouri
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New York
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Country [13]
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United States of America
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North Carolina
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Country [14]
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United States of America
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State/province [14]
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Ohio
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Country [15]
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United States of America
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State/province [15]
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Oregon
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Texas
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Utah
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United States of America
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Longboard Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05364021
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dennis J Dlugos, MD
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Address
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Children's Hospital of Philadelphia
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05364021
Download to PDF