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)
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ClinicalTrials.gov Identifier: NCT03694275 |
Recruitment Status :
Completed
First Posted : October 3, 2018
Last Update Posted : August 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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15q Duplication Syndrome CDKL5 Deficiency Disease | Drug: TAK-935 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study) |
Actual Study Start Date : | September 10, 2018 |
Actual Primary Completion Date : | July 13, 2020 |
Actual Study Completion Date : | July 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: TAK-935 (OV935)
Treatment: 8 weeks dose optimization followed by 12 weeks maintenance period.
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Drug: TAK-935
TAK-935 tablets or mini-tablets. |
- Percent Change from Baseline in Motor Seizure Frequency During the Maintenance Period [ Time Frame: up to 12 weeks ]
- Percentage of Participants Considered as Treatment Responders During the Maintenance Period [ Time Frame: up to 12 weeks ]
- Percent Change from Baseline in Motor Seizure Frequency During the Treatment Period [ Time Frame: up to 20 weeks ]
- Change from Baseline in Clinician's Global Impression of Severity and Change (CGI-S/C) Responses of Investigator [ Time Frame: up to 20 weeks ]
- Correlation of plasma 24S-hydroxycholesterol (24HC) Levels and change in motor seizures [ Time Frame: up to 20 weeks ]
- Change from Baseline in Care Clinical Global Impression of Change (CGI-C) Responses of Parent/Family [ Time Frame: up to 20 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of 15q duplication syndrome or CDKL5 deficiency disorder
- Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose
Exclusion Criteria:
- Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation
- Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month

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): NCT03694275
United States, California | |
UCLA | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Research Institute Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Georgia | |
Center for Rare Neurological Diseases | |
Norcross, Georgia, United States, 30093 | |
United States, Massachusetts | |
Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Boston Children's Hospital Translational Neuroscience Center | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Minnesota Epilepsy Group, P.A. | |
Saint Paul, Minnesota, United States, 55102 | |
United States, New York | |
New York University (NYU) | |
New York, New York, United States, 10017 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Study Director: | Medical Director | Takeda |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT03694275 |
Other Study ID Numbers: |
TAK-935-18-002 (OV935) U1111-1219-5787 ( Registry Identifier: WHO ) |
First Posted: | October 3, 2018 Key Record Dates |
Last Update Posted: | August 14, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Drug Therapy 15q Duplication Syndrome CDKL5 Deficiency Disease Brain Diseases Epilepsy Central Nervous System Diseases |
Autism Cholesterol 24S-hydroxylase inhibitor Anti-epilepsy drug Anticonvulsants Cyclin-dependent kinase-like 5 deficiency disorder Chromosome 15q |
Deficiency Diseases Syndrome Disease |
Pathologic Processes Malnutrition Nutrition Disorders |