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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03650452




Registration number
NCT03650452
Ethics application status
Date submitted
27/08/2018
Date registered
28/08/2018
Date last updated
7/08/2019

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 Patients With Developmental and/or Epileptic Encephalopathies
Scientific title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies
Secondary ID [1] 0 0
U1111-1206-5522
Secondary ID [2] 0 0
TAK-935-2002
Universal Trial Number (UTN)
Trial acronym
ELEKTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Dravet Syndrome 0 0
Lennox-Gastaut Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Neurological 0 0 0 0
Epilepsy
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-935
Treatment: Drugs - Placebo

Experimental: TAK-935 - Treatment: Eight weeks Dose Optimization Period followed by 12 weeks Maintenance Period.

Placebo Comparator: Placebo - Treatment: Eight weeks Dose Optimization Period followed by 12 weeks Maintenance Period.


Treatment: Drugs: TAK-935
TAK-935 tablets or mini-tablets.

Treatment: Drugs: Placebo
TAK-935 placebo-matching tablets or mini-tablets.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change from baseline in frequency of all seizures (convulsive and drop) per 28 days in patients receiving TAK-935 (OV935) as compared to placebo during the Maintenance Period
Timepoint [1] 0 0
up to 12 weeks
Secondary outcome [1] 0 0
Percent change from baseline in all seizures (convulsive and drop) in patients receiving TAK-935 (OV935) as compared to placebo during Treatment Period
Timepoint [1] 0 0
up to 20 weeks
Secondary outcome [2] 0 0
Percent change from baseline in frequency of convulsive seizures in Dravet patients and drop seizures in Lennox Gastaut syndrome (LGS) patients, respectively, receiving TAK-935 (OV935) as compared to placebo during Maintenance Period
Timepoint [2] 0 0
up to 12 weeks
Secondary outcome [3] 0 0
Percentage of patients receiving TAK-935 (OV935) as compared to placebo in the Dravet Syndrome Stratum and LGS Stratum, respectively, considered treatment responders throughout Maintenance Period
Timepoint [3] 0 0
up to 12 weeks
Secondary outcome [4] 0 0
Change in Clinician's and Caregiver's Clinical Global Impression of Severity and Change (CGI-S/C)
Timepoint [4] 0 0
up to 20 weeks
Secondary outcome [5] 0 0
Correlation of TAK-935 concentration and plasma 24S-hydroxycholesterol (24HC) levels
Timepoint [5] 0 0
up to 20 weeks

Eligibility
Key inclusion criteria
1. Male and female patients aged greater than or equal to (>=) 2 and less than or equal
to (<=) 17 years

2. Clinical diagnosis of Dravet Syndrome or LGS

3. Weight of >=10 kilogram (kg) at the Screening visit

4. Currently taking 1 to 4 anti-epileptic drugs (AED) at a stable dose

5. Failed to become and remain seizure free with trials of at least 2 AEDs
Minimum age
2 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg West
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Changsha
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shenzhen
Country [17] 0 0
Israel
State/province [17] 0 0
Bear Sheva
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Holon
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Petach Tikva
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Aviv
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Hashomer
Country [24] 0 0
Poland
State/province [24] 0 0
Pomorskie
Country [25] 0 0
Poland
State/province [25] 0 0
Swietokrzyskie
Country [26] 0 0
Poland
State/province [26] 0 0
Wielkopolskie
Country [27] 0 0
Poland
State/province [27] 0 0
Krakow
Country [28] 0 0
Portugal
State/province [28] 0 0
Lisboa
Country [29] 0 0
Portugal
State/province [29] 0 0
Porto
Country [30] 0 0
Spain
State/province [30] 0 0
Navarre
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ovid Therapeutics Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the effect on the frequency of all seizures
(convulsive and drop) in patients treated with TAK-935 compared to placebo.
Trial website
https://clinicaltrials.gov/show/NCT03650452
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
Ovid Therapeutics Call Center
Address 0 0
Country 0 0
Phone 0 0
+1-646-661-7661
Fax 0 0
Email 0 0
clinical@ovidrx.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03650452