A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Participants With 15Q Duplication Syndrome or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 2 - 35 |
Updated: | 4/5/2019 |
Start Date: | September 10, 2018 |
End Date: | September 11, 2020 |
Contact: | Ovid Call Centre |
Email: | clinical@ovidrx.com |
Phone: | 646-661-7661 |
A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)
The purpose of this study is to investigate the effect of TAK-935 on the frequency of motor
seizures for participants with 15q duplication syndrome or CDKL5 deficiency disorder during
the Maintenance Period.
seizures for participants with 15q duplication syndrome or CDKL5 deficiency disorder during
the Maintenance Period.
The drug being tested in this study is called TAK-935 (OV935). TAK-935 is being tested to
treat people with 15q duplication syndrome or CDKL5 deficiency disorder. This study will
assess the effects of TAK-935 on seizure frequency, safety.
The study will enroll approximately 30 participants. Participants will be enrolled into 2
groups based on their diagnosis as: 15q duplication syndrome or CDKL5 deficiency disorder.
All participants will be asked to take TAK-935 tablets twice daily with or without food.
The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose
Optimization and Maintenance). The overall time to participate in this study approximately 30
weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2 weeks
Taper, and 2 weeks safety follow up period. Participants completing this study will have an
option to enroll in the open-label extension (OLE) study, under a separate protocol.
treat people with 15q duplication syndrome or CDKL5 deficiency disorder. This study will
assess the effects of TAK-935 on seizure frequency, safety.
The study will enroll approximately 30 participants. Participants will be enrolled into 2
groups based on their diagnosis as: 15q duplication syndrome or CDKL5 deficiency disorder.
All participants will be asked to take TAK-935 tablets twice daily with or without food.
The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose
Optimization and Maintenance). The overall time to participate in this study approximately 30
weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2 weeks
Taper, and 2 weeks safety follow up period. Participants completing this study will have an
option to enroll in the open-label extension (OLE) study, under a separate protocol.
Inclusion Criteria:
1. Clinical diagnosis of 15q duplication syndrome or CDKL5 deficiency disorder
2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose
Exclusion Criteria:
1. One or more episodes of convulsive status epilepticus per week requiring
hospitalization and intubation
2. Currently receiving a study drug or participated in a clinical study involving another
investigational product in the previous month
We found this trial at
8
sites
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Boston, Massachusetts 02114
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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