Phase
Condition
Tic Disorders
Neuronal Ceroid Lipofuscinoses (Ncl)
Autism
Treatment
LP352
Clinical Study ID
Ages 2-66 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8,and who, in the opinion of the investigator, may benefit from continued LP352administration.
Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS),or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
Participant has a body weight of ≥10 kg.
G-tubes/PEG tubes (if applicable) should be in stable and good working condition.Nasogastric tubes are not allowed except for short-term management.
Has at least one reliable and consistent parent, legal guardian, or caregiver duringthe study.
The participant must be willing and able to provide written informed consent; ininstances where the participant is unable to provide consent, an appropriate LARmust provide informed consent and the participant will need to assent (as per localregulations) before participation in the study. If the participant cannot provideconsent or assent (ie, due to developmental status), the investigator shoulddocument why it was not obtained.
The participant and/or authorized representative is willing to provide writtenconsent or assent to allow the investigator and the investigator's staff to consultwith the participant's medical caregivers and the medical monitor during Screeningand during participation in the study.
All participants of childbearing potential must have a negative urine or serumpregnancy (human chorionic gonadotropin) test at Visit 8 from Study LP352-301 orLP352-302 and agrees to routinely use an acceptable effective method ofcontraception from the time of signing informed consent up to 48 hours after thelast dose of study drug.
Participant and/or participant's caregiver(s) agree to not post any participant'spersonal medical data related to the study or information related to the study onany website or social media site until the study has been completed.
The participant, parent, or caregiver is willing and able (in the judgment of theinvestigator) to comply with completion of the diaries throughout the study.
Exclusion
Exclusion Criteria:
The participant is receiving exclusionary medications.
Considered at risk of suicidal behavior based on the C-SSRS at Visit 8 of LP352-301or LP352-302. If the participant is unable to complete the C-SSRS due todevelopmental status, the participant's LAR may not complete the C-SSRS. In thesecases, the investigator may use clinical judgment to assess both the participant'sstatus regarding suicidality and the ability to complete the scale, both of whichmust then be documented in the source document.
Has a PHQ-9 score of >9 or a positive response to Question 9 at Visit 8 of LP352-301or LP352-302. If the participant is unable to complete the PHQ-9, the participant'sLAR may not complete the PHQ-9. In these cases, the investigator may use clinicaljudgment to assess both the participant's status and ability to complete the scale,both of which must then be documented in the source document.
Ongoing AE from LP352-301 or LP352-302 of severe depression, anorexia nervosa, orbulimia per the Diagnostic and Statistical Manual of Mental Disorders, FifthEdition.
Has an abnormal and clinically significant 12-lead ECG at Visit 8 in LP352-301 orLP352-302 in the opinion of the investigator, for example, second- or third-degreeheart block or a QTc of >450 msec for adult males, >470 msec for adult females, or >440 msec for pediatric participants.
Ongoing AE in LP352-301 or LP352-302 of alcohol, opioid, or other drug use disorder,as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Current use of any cannabis product or cannabidiol that is not in oralsolution/capsule/tablet form, not obtained from a government-approved dispensary, orcontaining ≥50% THC. Cannabis product or cannabidiol should be used primarily totreat seizures and dose should not be adjusted for the duration of the study.Cannabis product or cannabidiol will count as a concurrent ASM.
Has a positive result on the urine drug screen at Visit 8 of LP352-301 or LP352-302,except for positive results related to prescribed controlled medications (eg,benzodiazepine) or Epidiolex®/government-approved cannabis product/cannabidiol usedto treat seizures (eg, tetrahydrocannabinol).
Unstable, clinically significant neurologic (other than the disease being studied,eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterialhypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary,hepatic (severe hepatic impairment), renal (severe renal impairment), metabolic,gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease orother abnormality at Visit 8 of LP352-301 or LP352-302 which may impact the abilityof the participant to participate or potentially confound the study results.
Is pregnant, breast-feeding, or intending to become pregnant during or within 48hours after the last dose of study drug; or intending to donate ova during such timeperiod.
Has a known hypersensitivity to any component of LP352 formulation or any history ofserious drug-induced hypersensitivity, eg, toxic epidermal necrolysis or DrugReaction with Eosinophilia and Systemic Symptoms.
Unwilling to abstain from donation of blood during and within 2 weeks after thestudy.
Is unable or unwilling to comply with any of the study requirements or timelines.
Study Design
Connect with a study center
Site Number - AUS07
Randwick, New South Wales 2031
AustraliaSite Not Available
Site Number - AUS08
Randwick, New South Wales 2031
AustraliaSite Not Available
Site Number - AUS04
Herston, Queensland 4006
AustraliaSite Not Available
Site Number - AUS05
South Brisbane, Queensland 4101
AustraliaSite Not Available
Site Number - AUS02
Heidelberg, Victoria 3084
AustraliaSite Not Available
Site Number - AUS03
Melbourne, Victoria 3004
AustraliaSite Not Available
Austin Hospital
Heidelberg 2163654, Victoria 2145234 3084
AustraliaSite Not Available
AP-HP - Hôpital universitaire Robert-Debré
Paris 2988507, 75019
FranceSite Not Available
Children's Clinical University Hospital
Riga 456172, LV-1004
LatviaSite Not Available
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade 792680, 11000
SerbiaSite Not Available
Hospital de La Santa Creu i Sant Pau
Barcelona 3128760, 8041
SpainSite Not Available
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid 3117735, 28034
SpainSite Not Available
Hospital Universitario Vithas Madrid La Milagrosa
Madrid 3117735, 28010
SpainSite Not Available
Site Number - USA19
Little Rock, Arkansas 72202
United StatesSite Not Available
Arkansas Children's Hospital - PIN
Little Rock 4119403, Arkansas 4099753 72202-3500
United StatesSite Not Available
Site Number - USA29
La Jolla, California 92037
United StatesSite Not Available
Site Number - USA18
Los Angeles, California 90095
United StatesSite Not Available
Site Number - USA26
Los Angeles, California 90027
United StatesSite Not Available
Site Number - USA24
Palo Alto, California 94304
United StatesSite Not Available
Site Number - USA28
San Francisco, California 94904
United StatesSite Not Available
David Geffen School of Medicine at UCLA
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Site Number - USA17
Aurora, Colorado 80045
United StatesSite Not Available
Site Number - USA02
Gulf Breeze, Florida 32561
United StatesSite Not Available
Site Number - USA37
Miami, Florida 33155
United StatesSite Not Available
Site Number - USA05
Orlando, Florida 32806
United StatesSite Not Available
Site Number - USA11
Tampa, Florida 33609
United StatesSite Not Available
NW FL Clinical Research Group, LLC
Gulf Breeze 4157634, Florida 4155751 32561-4458
United StatesSite Not Available
Research Institute of Orlando LLC
Orlando 4167147, Florida 4155751 32806-5411
United StatesSite Not Available
Pediatric Epilepsy and Neurology Specialists
Tampa 4174757, Florida 4155751 33609-4181
United StatesSite Not Available
Site Number - USA09
Atlanta, Georgia 30329
United StatesSite Not Available
Site Number - USA38
Chicago, Illinois 60611
United StatesSite Not Available
Site Number - USA07
Bethesda, Maryland 20817
United StatesSite Not Available
Mid-Atlantic Epilepsy and Sleep Center
Bethesda 4348599, Maryland 4361885 20817-1809
United StatesSite Not Available
Site Number - USA15
Rochester, Minnesota 55905
United StatesSite Not Available
Site Number - USA10
Livingston, New Jersey 07039
United StatesSite Not Available
Site Number - USA36
Morristown, New Jersey 07961
United StatesSite Not Available
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston 5100572, New Jersey 5101760 07039-5817
United StatesSite Not Available
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
Site Number - USA32
New York, New York 10016
United StatesSite Not Available
Site Number - USA14
Cincinnati, Ohio 45229
United StatesSite Not Available
Site Number - USA39
Cleveland, Ohio 44195
United StatesSite Not Available
Site Number - USA35
Columbus, Ohio 43205
United StatesSite Not Available
Site Number - USA33
Portland, Oregon 97239
United StatesSite Not Available
Site Number - USA22
Charleston, South Carolina 29425
United StatesSite Not Available
Site Number - USA34
Memphis, Tennessee 38103
United StatesSite Not Available
Site Number - USA31
Fort Worth, Texas 76104
United StatesSite Not Available
Site Number - USA25
Houston, Texas 77030
United StatesSite Not Available
The University of Texas Medical School at Houston
Houston 4699066, Texas 4736286 77030-3000
United StatesSite Not Available
Site Number - USA03
Tacoma, Washington 98405
United StatesSite Not Available

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