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Trial record 2 of 3 for:    elektra

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)

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ClinicalTrials.gov Identifier: NCT03650452
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to investigate the efficacy, safety and tolerability of TAK-935 (OV935), compared to placebo, as an adjunctive therapy in pediatric patients with epileptic seizures associated with Dravet Syndrome and Lennox-Gastaut Syndrome (LGS).

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 participants.

Participants 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 14 weeks including 2-week Titration Period and 12-week Maintenance Period. The overall time to participate in this study is approximately 24 weeks.

Participants 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)
Estimated Enrollment : 126 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 : March 21, 2021
Estimated Study Completion Date : April 21, 2021


Arm Intervention/treatment
Experimental: TAK-935
Treatment: two weeks titration followed by 12 weeks maintenance period.
Drug: TAK-935
TAK-935 tablets or mini-tablets

Placebo Comparator: Placebo
Treatment: two weeks titration 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 Treatment Period [ Time Frame: up to 14 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 Maintenance Period [ Time Frame: up to 14 weeks ]
  2. Percent change from baseline in frequency of convulsive seizures in Dravet patients and drop seizures in LGS patients, respectively, receiving TAK-935 (OV935) as compared to placebo during Treatment Period [ Time Frame: up to 14 weeks ]
  3. Proportion of patients receiving TAK-935 (OV935) as compared to placebo in the Dravet patients and LGS patients, respectively, considered treatment responders [ Time Frame: up to 14 weeks ]
  4. Change in Clinician's and Caregiver's Clinical Global Impression of Severity and Change [ Time Frame: up to 14 weeks ]
  5. Correlation of TAK-935 concentration and plasma 24S-hydroxycholesterol (24HC) levels [ Time Frame: up to 14 weeks ]


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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 ≥2 and ≤17 years
  2. Clinical diagnosis of Dravet Syndrome or LGS
  3. Weight of ≥10 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. On average 1 or more episodes of convulsive status epilepticus requiring hospitalization per week 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


Contacts
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Contact: Ovid Therapeutics Call Center +1-646-661-7661 clinical@ovidrx.com

Locations
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United States, Colorado
Colorado Children's Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Pediatric Neurology PA Recruiting
Orlando, Florida, United States, 32819
United States, Georgia
Rare Disease Research, LLC Recruiting
Atlanta, Georgia, United States, 30318
Center for Rare Neurological Diseases Recruiting
Norcross, Georgia, United States, 30093
United States, Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic - PPDS Recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Northeast Regional Epilepsy Group Recruiting
Hackensack, New Jersey, United States, 07601
Children's Hospital at Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Sponsors and Collaborators
Takeda
Ovid Therapeutics Inc.
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03650452     History of Changes
Other Study ID Numbers: TAK-935-2002
U1111-1206-5522 ( Other Identifier: World Health Organization )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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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Syndrome
Epilepsy
Brain Diseases
Lennox Gastaut Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Genetic Diseases, Inborn
Epilepsy, Generalized