A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - 65
Updated:3/8/2019
Start Date:July 19, 2018
End Date:April 21, 2023
Contact:Ovid Call Center
Email:clinical@ovidrx.com
Phone:646-661-7661

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The main purpose of this study is to investigate the long-term safety and tolerability of
TAK-935/OV935 as an adjunctive therapy in patients with epileptic seizures.

The drug being tested in this study is called TAK-935 (OV935). This global, open-label study
will assess the safety and tolerability of TAK-935 for 2 years in patients who participated
in previous short-term efficacy/safety studies of TAK-935. All patients will receive TAK-935
treatment.

Patients who rollover from previous blinded study will undergo up to 2 weeks of titration
followed by 102 weeks of maintenance period. Patients who rollover from an open-label study
will continue on their current dose for 104 weeks. There will be a 4-week safety follow-up
after the last dose, including a 2-week dose tapering period.

Inclusion Criteria:

1. Patients must have participated in a previous TAK-935 study and meet one of the
following conditions:

- Successfully completed a TAK-935 clinical study

- In the opinion of the investigator, the patient has the potential to benefit from the
administration of TAK-935

Exclusion Criteria:

1. Clinically significant disease, that, in the investigator's opinion, precludes study
participation

2. Enrollment in any other clinical trial involving an investigational drug, device, or
treatment in the past 6 months (with the exception of an antecedent study involving
TAK-935)
We found this trial at
10
sites
Saint Paul, Minnesota
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7485 Sandlake Commons Blvd.
Orlando, Florida 32835
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Orlando, FL
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Atlanta, Georgia 30318
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Atlanta, GA
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Chesterfield, Missouri 63017
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Chesterfield, MO
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Hackensack, New Jersey 07601
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Hackensack, NJ
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Lexington, Kentucky 40504
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Lexington, KY
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5600 Oakbrook Parkway
Norcross, Georgia 30093
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Norcross, GA
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Phoenix, Arizona 85004
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Phoenix, AZ
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Port Charlotte, Florida 33952
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Port Charlotte, FL
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