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Trial record 2 of 10 for:    TAK-935

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 (ELEKTRA)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650452
Recruitment Status : Active, not recruiting
First Posted : August 28, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Epilepsy Dravet Syndrome Lennox-Gastaut Syndrome Drug: TAK-935 Drug: Placebo Phase 2

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 patients with Dravet syndrome or LGS. This multi-center trial will be conducted worldwide and will enroll approximately 126 patients.

Patients will be randomized based on their diagnosis in 2 categories; Dravet syndrome and LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to patients in this study is approximately 30 weeks.

Patients completing this study will have an option to enroll in the open-label extension study, under a separate protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: TAK-935
Treatment: Eight weeks Dose Optimization Period followed by 12 weeks Maintenance Period.
Drug: TAK-935
TAK-935 tablets or mini-tablets.

Placebo Comparator: Placebo
Treatment: Eight weeks Dose Optimization Period followed by 12 weeks Maintenance Period.
Drug: Placebo
TAK-935 placebo-matching tablets or mini-tablets.




Primary Outcome Measures :
  1. 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 [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline in all seizures (convulsive and drop) in patients receiving TAK-935 (OV935) as compared to placebo during Treatment Period [ Time Frame: up to 20 weeks ]
  2. 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 [ Time Frame: up to 12 weeks ]
  3. 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 [ Time Frame: up to 12 weeks ]
  4. Change in Clinician's and Caregiver's Clinical Global Impression of Severity and Change (CGI-S/C) [ Time Frame: up to 20 weeks ]
  5. Correlation of TAK-935 concentration and plasma 24S-hydroxycholesterol (24HC) levels [ Time Frame: up to 20 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650452


Locations
Hide Hide 44 study locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Colorado Children's Hospital
Aurora, Colorado, United States, 80045
United States, Florida
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Pediatric Neurology PA
Orlando, Florida, United States, 32819
United States, Georgia
Rare Disease Research, LLC
Atlanta, Georgia, United States, 30318
Center for Rare Neurological Diseases
Norcross, Georgia, United States, 30093
United States, Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic - PPDS
Rochester, Minnesota, United States, 55905
United States, New Jersey
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Australia, Victoria
Monash Children's Hospital
Clayton, Victoria, Australia, 3168
Austin Hospital
Heidelberg West, Victoria, Australia, 3081
Canada, Ontario
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
China
Peking University First Hospital
Beijing, China, 100034
Capital Medical University (CMU) - Beijing Children's Hospital
Beijing, China, 100045
Beijing Children's Hospital,Capital Medical University
Beijing, China, 100069
Xiangya Hospital Central South University
Changsha, China, 410078
Children's Hospital of Fudan University
Shanghai, China, 201102
Shenzhen Children's Hospital
Shenzhen, China, 518026
Israel
Sheba Medical Center-PPDS
Tel Hashomer,, Ramat Gan, Israel, 52621
Soroka University Medical Centre
Bear Sheva, Israel, 84101
Bnai Zion Medical Center
Haifa, Israel, 31048
Edith Wolfson Medical Center
Holon, Israel, 58100
Hadassah Medical Center
Jerusalem, Israel, 91120
Schneider Childrens Medical Center of Israel
Petach Tikva, Israel, 49202
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Poland
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Pomorskie, Poland, 80-211
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Swietokrzyskie, Poland, 25-316
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Wielkopolskie, Poland, 60-355
Centrum Medyczne Plejady
Krakow, Poland, 30-363
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, Poland, 02-091
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Portugal
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisboa, Portugal, 1169-045
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte
Porto, Portugal, 4050-651
Spain
Clinica Universidad Navarra
Pamplona, Navarra, Spain, 31008
Hospital Vithas La Salud
Granada, Spain, 18008
Hospital Ruber Internacional
Madrid, Spain, 28034
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Sponsors and Collaborators
Takeda
Ovid Therapeutics Inc.
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03650452    
Other Study ID Numbers: TAK-935-2002
U1111-1206-5522 ( Other Identifier: World Health Organization )
2018‐002484‐25 ( EudraCT Number )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Brain Diseases
Central Nervous System Diseases
Tuberous Sclerosis
CDKL5 deficiency disorder
Duplication 15 Q syndrome
Dup15Q syndrome
Anoxic brain injury
Infantile spams
West syndrome
Cortical dysplasia
SCN1A
OV-935
Cholesterol 24 hydroxylase inhibitor
Cholesterol 24S-hydroxylase inhibitor
Seizure
Anti-epilepsy drug
Anticonvulsants
Nervous System Diseases
Drop seizure
Atonic seizure
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Epilepsies, Myoclonic
Lennox Gastaut Syndrome
Syndrome
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes
Genetic Diseases, Inborn