Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/NCT03650452
Registration number
NCT03650452
Ethics application status
Date submitted
27/08/2018
Date registered
28/08/2018
Titles & IDs
Public title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Query!
Scientific title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies
Query!
Secondary ID [1]
0
0
U1111-1206-5522
Query!
Secondary ID [2]
0
0
TAK-935-2002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ELEKTRA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epilepsy
0
0
Query!
Dravet Syndrome
0
0
Query!
Lennox-Gastaut Syndrome
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TAK-935
Treatment: Drugs - Placebo
Placebo comparator: Placebo - TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20.
Experimental: TAK-935 - TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing \<60 kg received total daily dose of study drug calculated based on body weight. Participants weighing =60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
Treatment: Drugs: TAK-935
TAK-935 tablets or mini-tablets.
Treatment: Drugs: Placebo
TAK-935 placebo-matching tablets or mini-tablets.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period
Query!
Assessment method [1]
0
0
Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement.
Query!
Timepoint [1]
0
0
Baseline; Maintenance Period: Weeks 9 to 20
Query!
Secondary outcome [1]
0
0
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period
Query!
Assessment method [1]
0
0
Seizure Frequency per 28 days is defined as total number of Seizures reported (convulsive seizures for DS, drop seizures for LGS) during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent Change from Baseline is defined as (frequency of seizures per 28 days during treatment period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement.
Query!
Timepoint [1]
0
0
Baseline; Treatment Period: Weeks 0 to 20
Query!
Secondary outcome [2]
0
0
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period
Query!
Assessment method [2]
0
0
Convulsive seizure frequency per 28 days is defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent Change from Baseline (%) is defined as \[(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency\] multiplied by 100. Negative percent change from Baseline indicates improvement.
Query!
Timepoint [2]
0
0
Baseline; Maintenance Period: Weeks 9 to 20
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period
Query!
Assessment method [3]
0
0
Drop seizure frequency per 28 days is defined as total number of drop seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent Change from Baseline (%) is defined as \[(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency\] multiplied by 100. Negative percent change from Baseline indicates improvement.
Query!
Timepoint [3]
0
0
Baseline; Maintenance Period: Weeks 9 to 20
Query!
Secondary outcome [4]
0
0
Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period
Query!
Assessment method [4]
0
0
Responders are defined as having over 50% drop seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as \[(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency\] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline.
Query!
Timepoint [4]
0
0
Maintenance Period: Weeks 9 to 20
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period
Query!
Assessment method [5]
0
0
Responders are defined as having over 50% convulsive seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as \[(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency\] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline.
Query!
Timepoint [5]
0
0
Maintenance Period: Weeks 9 to 20
Query!
Secondary outcome [6]
0
0
Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug
Query!
Assessment method [6]
0
0
The CGI-Severity (CGI-S) focuses on clinicians' observations of the participant's cognitive, functional, and behavioral performance since the beginning of the study. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill participants). A negative change from Baseline indicates improvement.
Query!
Timepoint [6]
0
0
Baseline and Week 20
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935
Query!
Assessment method [7]
0
0
CGI-Change (CGI-C) treatment response ratings should take account of both therapeutic efficacy and treatment-related AEs. Each component of the CGI is rated separately; the instrument does not yield a global score. The CGI-C is rated on a 7-point scale, where, 0 = Marked improvement and no side-effects, 1 = Marked improvement and minimal side-effects, 2 = No Change, 3 = Minimal improvement and marked side-effects and 4 = Unchanged or worse and side-effects outweigh the therapeutic effect. Lower scores indicated improvement.
Query!
Timepoint [7]
0
0
Week 20
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935
Query!
Assessment method [8]
0
0
The Care GI-C is rated on a 7-point scale, with the severity of illness scale where, 1 = Very much improved, 2 = Much improved, 3 = Slightly improved, 4 = No change, 5 = Slightly worse, 6 = Much worse and 7 = Very much worse. Lower scores indicated improvement.
Query!
Timepoint [8]
0
0
Week 20
Query!
Secondary outcome [9]
0
0
Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy
Query!
Assessment method [9]
0
0
A negative change from Baseline indicates improvement.
Query!
Timepoint [9]
0
0
Baseline and Week 24
Query!
Secondary outcome [10]
0
0
Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy
Query!
Assessment method [10]
0
0
Seizure frequency was based on convulsive seizures for the participants in the Dravet Syndrome Indication and Drop Seizures for the participants in the LGS Indication. Seizure frequency per 28 days = (total number of seizures reported during the period) / (number of days during the period seizures were assessed) \* 28. A negative change from Baseline indicates improvement.
Query!
Timepoint [10]
0
0
Baseline and Week 20
Query!
Eligibility
Key inclusion criteria
1. Male and female participants aged greater than or equal to (>=) 2 and less than or equal to (<=) 17 years
2. Clinical diagnosis of DS or LGS
3. Weight of >=10 kilogram (kg) at the Screening visit
4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose
5. Failed to become and remain seizure free with trials of at least 2 AEDs
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Has been admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately prior to the screening visit
2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures
3. Participation in a clinical study involving another study drug in the previous month
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/08/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/07/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
141
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Children's Hospital - Clayton
Query!
Recruitment hospital [2]
0
0
Austin Hospital - Heidelberg West
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
3081 - Heidelberg West
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Ontario
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Beijing
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Changsha
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Shanghai
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Shenzhen
Query!
Country [18]
0
0
Israel
Query!
State/province [18]
0
0
Ramat Gan
Query!
Country [19]
0
0
Israel
Query!
State/province [19]
0
0
Bear Sheva
Query!
Country [20]
0
0
Israel
Query!
State/province [20]
0
0
Haifa
Query!
Country [21]
0
0
Israel
Query!
State/province [21]
0
0
Holon
Query!
Country [22]
0
0
Israel
Query!
State/province [22]
0
0
Jerusalem
Query!
Country [23]
0
0
Israel
Query!
State/province [23]
0
0
Petach Tikva
Query!
Country [24]
0
0
Israel
Query!
State/province [24]
0
0
Tel Aviv
Query!
Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Pomorskie
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Swietokrzyskie
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Wielkopolskie
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Krakow
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Warsaw
Query!
Country [30]
0
0
Portugal
Query!
State/province [30]
0
0
Lisboa
Query!
Country [31]
0
0
Portugal
Query!
State/province [31]
0
0
Porto
Query!
Country [32]
0
0
Spain
Query!
State/province [32]
0
0
Navarra
Query!
Country [33]
0
0
Spain
Query!
State/province [33]
0
0
Granada
Query!
Country [34]
0
0
Spain
Query!
State/province [34]
0
0
Madrid
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Takeda
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Ovid Therapeutics Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03650452
Query!
Trial related presentations / publications
Hahn CD, Jiang Y, Villanueva V, Zolnowska M, Arkilo D, Hsiao S, Asgharnejad M, Dlugos D. A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA). Epilepsia. 2022 Oct;63(10):2671-2683. doi: 10.1111/epi.17367. Epub 2022 Aug 4.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director Clinical Science
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/52/NCT03650452/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/52/NCT03650452/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03650452