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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 : Recruiting
First Posted : October 3, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
15q Duplication Syndrome CDKL5 Deficiency Disease Drug: TAK-935 Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : August 14, 2020
Estimated Study Completion Date : September 11, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAK-935 (OV935)
Treatment: 8 weeks dose optimization followed by 12 weeks maintenance period.
 Drug: TAK-935
TAK-935 tablets or mini-tablets.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Motor Seizure Frequency During the Maintenance Period [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants Considered as Treatment Responders During the Maintenance Period [ Time Frame: up to 12 weeks ]
  2. Percent Change from Baseline in Motor Seizure Frequency During the Treatment Period [ Time Frame: up to 20 weeks ]
  3. Change from Baseline in Clinician's Global Impression of Severity and Change (CGI-S/C) Responses of Investigator [ Time Frame: up to 20 weeks ]
  4. Correlation of plasma 24S-hydroxycholesterol (24HC) Levels and change in motor seizures [ Time Frame: up to 20 weeks ]
  5. Change from Baseline in Care Clinical Global Impression of Change (CGI-C) Responses of Parent/Family [ Time Frame: up to 20 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation
  2. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month
Contacts and Locations
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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): NCT03694275


Contacts
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Contact: Ovid Call Centre 646-661-7661 ARCADE@ovidrx.com

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Research Institute Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Center for Rare Neurological Diseases Active, not recruiting
Norcross, Georgia, United States, 30093
United States, Massachusetts
Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Boston Children's Hospital Translational Neuroscience Center Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
Minnesota Epilepsy Group, P.A. Recruiting
Saint Paul, Minnesota, United States, 55102
United States, New York
New York University (NYU) Recruiting
New York, New York, United States, 10017
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Takeda
Ovid Therapeutics Inc.
Investigators
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Study Director: Medical Director Takeda
More Information
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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: February 12, 2020
Last Verified: February 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.

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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
15q Duplication Syndrome
CDKL5 Deficiency Disease
Brain Diseases
Epilepsy
Central Nervous System Diseases
Autism
 Infantile spams
Cholesterol 24S-hydroxylase inhibitor
Anti-epilepsy drug
Anticonvulsants
Cyclin-dependent kinase-like 5 deficiency disorder
RETT syndrome
Chromosome 15q
Additional relevant MeSH terms:
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Deficiency Diseases
Syndrome
Disease
 Pathologic Processes
Malnutrition
Nutrition Disorders