Register a trial

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06660394




Registration number
NCT06660394
Ethics application status
Date submitted
24/10/2024
Date registered
28/10/2024

Titles & IDs
Public title
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome
Secondary ID [1] 0 0
2024-514937-39-00
Secondary ID [2] 0 0
LP352-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dravet Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LP352
Treatment: Drugs - Placebo

Experimental: LP352 - Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.

Placebo comparator: Placebo - Placebo for LP352


Treatment: Drugs: LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube

Treatment: Drugs: Placebo
Participants will be administered with matching placebo orally or through G-tube/ PEG tube
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Timepoint [1] 0 0
Baseline and up to 15 Weeks
Secondary outcome [1] 0 0
Safety and Tolerability of LP352
Timepoint [1] 0 0
Up to 21 Weeks
Secondary outcome [2] 0 0
Percentage of participants with = 50% Reduction in countable motor seizures during Treatment compared to Baseline
Timepoint [2] 0 0
Baseline and up to 15 Weeks
Secondary outcome [3] 0 0
Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline
Timepoint [3] 0 0
Baseline and up to 15 Weeks

Eligibility
Key inclusion criteria
* Diagnosis of DS must fulfill all of the following criteria:

1. Participants with seizure onset age >1 and <20 months
2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
* The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic
* The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.
* The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
* The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
* The participant must be willing and able to provide written informed consent.
Minimum age
2 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant has a history of infantile/epileptic spasms.
* The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
* The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
* The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
* The participant is receiving exclusionary medications.
* The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains =50% Delta-9-tetrahydrocannabinol (THC).
* The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
* The participant is unwilling to comply with any of the study requirements or timelines.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site Number - AUS07 - Randwick
Recruitment hospital [2] 0 0
Site Number - AUS08 - Randwick
Recruitment hospital [3] 0 0
Site Number - AUS09 - Westmead
Recruitment hospital [4] 0 0
Site Number - AUS04 - Herston
Recruitment hospital [5] 0 0
Site Number - AUS05 - South Brisbane
Recruitment hospital [6] 0 0
Site Number - AUS02 - Heidelberg
Recruitment hospital [7] 0 0
Site Number - AUS03 - Melbourne
Recruitment hospital [8] 0 0
Site Number - AUS06 - Parkville
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Brazil
State/province [20] 0 0
SP
Country [21] 0 0
Brazil
State/province [21] 0 0
Curitiba
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
France
State/province [25] 0 0
Bron
Country [26] 0 0
France
State/province [26] 0 0
Lille
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Germany
State/province [32] 0 0
Bielefeld
Country [33] 0 0
Germany
State/province [33] 0 0
Bonn
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg im Breisgau
Country [36] 0 0
Germany
State/province [36] 0 0
Kiel
Country [37] 0 0
Germany
State/province [37] 0 0
Radeberg
Country [38] 0 0
Germany
State/province [38] 0 0
Ravensburg
Country [39] 0 0
Italy
State/province [39] 0 0
Genova
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Italy
State/province [42] 0 0
Toscana
Country [43] 0 0
Italy
State/province [43] 0 0
Verona
Country [44] 0 0
Latvia
State/province [44] 0 0
Riga
Country [45] 0 0
Mexico
State/province [45] 0 0
Cdmx
Country [46] 0 0
Netherlands
State/province [46] 0 0
BV
Country [47] 0 0
Portugal
State/province [47] 0 0
Coimbra
Country [48] 0 0
Portugal
State/province [48] 0 0
Lisbon
Country [49] 0 0
Portugal
State/province [49] 0 0
Porto Covo
Country [50] 0 0
Serbia
State/province [50] 0 0
Belgrade
Country [51] 0 0
Serbia
State/province [51] 0 0
Kragujevac
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Málaga
Country [55] 0 0
Spain
State/province [55] 0 0
Pamplona
Country [56] 0 0
Spain
State/province [56] 0 0
Valencia
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Glasgow
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Newcastle Upon Tyne
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Longboard Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Longboard Study Contact
Address 0 0
Country 0 0
Phone 0 0
858-999-8858
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06660394