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



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:2 - 17
Updated:2/17/2019
Start Date:August 8, 2018
End Date:April 21, 2021
Contact:Ovid Therapeutics Call Center
Email:clinical@ovidrx.com
Phone:+1-646-661-7661

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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

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).

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.

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
We found this trial at
11
sites
Atlanta, Georgia 30318
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7485 Sandlake Commons Blvd.
Orlando, Florida 32835
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Orlando, FL
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Aurora, Colorado 80045
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Aurora, CO
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Beijing,
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Hackensack, New Jersey 07601
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Hackensack, NJ
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Miami, Florida 33155
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Miami, FL
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New Brunswick, NJ
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5600 Oakbrook Parkway
Norcross, Georgia 30093
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Norcross, GA
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200 1st Street Southwest
Rochester, Minnesota 55905
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Rochester, MN
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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