EpilepsyPhase 2ELEKTRANCT03650452
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
A Phase 2 study testing TAK-935 in people with Epilepsy and Dravet Syndrome, run by Takeda at 44 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- What is being tested?
- TAK-935
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 44 sitesin 8 countries
- Study dates
- 8 Aug 2018to 20 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female participants aged greater than or equal to (>=) 2 and less than or equal to (<=) 17 years
- Clinical diagnosis of DS or LGS
- Weight of >=10 kilogram (kg) at the Screening visit
- Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose
- Failed to become and remain seizure free with trials of at least 2 AEDs
Who cannot join
- 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
- Non-epileptic events that cannot be reliably distinguished from epileptic seizures
- Participation in a clinical study involving another study drug in the previous month
Trial locations and contacts
44 sites in 8 countries.
44 sites in 8 countries
United States15 sites
Rare Disease Research, LLC
Atlanta, Georgia, 30318
Colorado Children's Hospital
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Cook Children's Medical Center
Fort Worth, Texas, 76104
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Children's Hospital Los Angeles
Los Angeles, California, 90027
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Columbia University Medical Center
New York, New York, 10032
Center for Rare Neurological Diseases
Norcross, Georgia, 30093
Pediatric Neurology PA
Orlando, Florida, 32819
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Mayo Clinic - PPDS
Rochester, Minnesota, 55905
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Israel7 sites
Soroka University Medical Centre
Bear Sheva, 84101
Bnai Zion Medical Center
Haifa, 31048
Edith Wolfson Medical Center
Holon, 58100
Hadassah Medical Center
Jerusalem, 91120
Schneider Childrens Medical Center of Israel
Petah Tikva, 49202
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center-PPDS
Tel Litwinsky, Ramat Gan, 52621
China6 sites
Peking University First Hospital
Beijing, 100034
Capital Medical University (CMU) - Beijing Children's Hospital
Beijing, 100045
Beijing Children's Hospital,Capital Medical University
Beijing, 100069
Xiangya Hospital Central South University
Changsha, 410078
Children's Hospital of Fudan University
Shanghai, 201102
Shenzhen Children's Hospital
Shenzhen, 518026
Poland6 sites
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Pomeranian Voivodeship, 80-211
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Świętokrzyskie Voivodeship, 25-316
Centrum Medyczne Plejady
Krakow, 30-363
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, 60-355
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, 02-091
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730
Spain4 sites
Hospital Vithas La Salud
Granada, 18008
Hospital Ruber Internacional
Madrid, 28034
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Portugal3 sites
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisbon, 1169-045
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, 1649-035
Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte
Porto, 4050-651
Australia2 sites
Monash Children's Hospital
Clayton, Victoria, 3168
Austin Hospital
Heidelberg West, Victoria, 3081
About this study
Official 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
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.
Read the detailed description
The drug being tested in this study is called TAK-935 (OV935). This randomized, double-blind study will assess the effects of TAK-935 (OV935), compared to placebo, on efficacy, safety, and tolerability in pediatric participants with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS). This multi-center trial will be conducted worldwide and will enroll approximately 126 participants.
Participants will be randomized based on their diagnosis in 2 categories; DS or LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is up to 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to participants in this study is approximately 30 weeks.
Participants completing this study will have an option to enroll in the open-label extension study, under a separate protocol.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Being tested
- TAK-935, Placebo
- Keywords
- Drug Therapy, Brain Diseases, Central Nervous System Diseases, Tuberous Sclerosis, CDKL5 deficiency disorder, Dup15Q syndrome, Anoxic brain injury, Infantile spams, West syndrome, Cortical dysplasia, SCN1A, OV-935, Cholesterol 24S-hydroxylase inhibitor, Seizure, Anti-epileptic drug, Anticonvulsants, Nervous System Diseases, Drop seizure, Atonic seizure
- Medical subject headings
- Epilepsy, Epilepsies, Myoclonic, Lennox Gastaut Syndrome, Brain Diseases, Central Nervous System Diseases, Tuberous Sclerosis, CDKL5 deficiency disorder, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-935Drug
TAK-935 tablets or mini-tablets.
PlaceboDrug
TAK-935 placebo-matching tablets or mini-tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20. Receives: Drug: Placebo |
| TAK-935 | Experimental | 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. Receives: Drug: TAK-935 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period
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.
Measured: Baseline; Maintenance Period: Weeks 9 to 20
Secondary outcomes (10)
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period
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.
Measured: Baseline; Treatment Period: Weeks 0 to 20
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period
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.
Measured: Baseline; Maintenance Period: Weeks 9 to 20
Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period
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.
Measured: Baseline; Maintenance Period: Weeks 9 to 20
Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period
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.
Measured: Maintenance Period: Weeks 9 to 20
Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period
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.
Measured: Maintenance Period: Weeks 9 to 20
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
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.
Measured: Baseline and Week 20
Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935
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.
Measured: Week 20
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
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.
Measured: Week 20
Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy
A negative change from Baseline indicates improvement.
Measured: Baseline and Week 24
Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy
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.
Measured: Baseline and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start8 Aug 2018
- Primary completion9 Jun 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healx AI
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650452
- Sponsor's protocol ID
- TAK-935-2002
- Other IDs
- U1111-1206-5522, 2018-002484-25, 2018
- Acronym
- ELEKTRA
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2018
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35841234
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03650452
- Acronym / sponsor ID
- ELEKTRA / TAK-935-2002
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Keywords
- Drug Therapy, Brain Diseases, Central Nervous System Diseases, Tuberous Sclerosis, CDKL5 deficiency disorder, Dup15Q syndrome, Anoxic brain injury, Infantile spams
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Healx AI
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study is called TAK-935 (OV935). This randomized, double-blind study will assess the effects of TAK-935 (OV935), compared to placebo, on efficacy, safety, and tolerability in pediatric participants with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS). This multi-center trial will be conducted worldwide and will enroll approximately 126 participants.
Participants will be randomized based on their diagnosis in 2 categories; DS or LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is up to 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to participants in this study is approximately 30 weeks.
Participants completing this study will have an option to enroll in the open-label extension study, under a separate protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20. |
| TAK-935 | Experimental | Drug: TAK-935TAK-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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and female participants aged greater than or equal to (>=) 2 and less than or equal to (<=) 17 years
- Clinical diagnosis of DS or LGS
- Weight of >=10 kilogram (kg) at the Screening visit
- Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose
- Failed to become and remain seizure free with trials of at least 2 AEDs
Key exclusion criteria (3 listed)
- 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
- Non-epileptic events that cannot be reliably distinguished from epileptic seizures
- Participation in a clinical study involving another study drug in the previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-935TAK-935 tablets or mini-tablets. | Drug | TAK-935 |
| PlaceboTAK-935 placebo-matching tablets or mini-tablets. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period
Time frame: Baseline; Maintenance Period: Weeks 9 to 20
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.
10 secondary outcomes
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period
Time frame: Baseline; Treatment Period: Weeks 0 to 20
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period
Time frame: Baseline; Maintenance Period: Weeks 9 to 20
Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period
Time frame: Baseline; Maintenance Period: Weeks 9 to 20
Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period
Time frame: Maintenance Period: Weeks 9 to 20
Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period
Time frame: Maintenance Period: Weeks 9 to 20
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
Time frame: Baseline and Week 20
Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935
Time frame: Week 20
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
Time frame: Week 20
Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy
Time frame: Baseline and Week 24
Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy
Time frame: Baseline and Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35841234Hahn 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-935 in people with Epilepsy and Dravet Syndrome, run by Takeda at 44 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Israel, China, Poland, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period (time frame: Baseline; Maintenance Period: Weeks 9 to 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.