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Trial record 82 of 58344 for:    Placebo

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 : June 14, 2019
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)
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: 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 ]


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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


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

  Show 30 Study Locations
Sponsors and Collaborators
Takeda
Ovid Therapeutics Inc.

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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 )
2018‐002484‐25 ( EudraCT Number )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 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