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Trial record 5 of 10 for:    TAK-935

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694275
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE September 10, 2018
Actual Primary Completion Date July 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
Percent Change from Baseline in Motor Seizure Frequency During the Maintenance Period [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Percent Change from Baseline in Motor Seizure Frequency [ Time Frame: up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Percentage of Participants Considered as Treatment Responders During the Treatment Period [ Time Frame: up to 12 weeks ]
  • Percent Change from Baseline in Motor Seizure Frequency During the Maintenance Period [ Time Frame: up to 8 weeks ]
  • Percent Change from Baseline in Clinician's Global Impression of Severity and Change (CGI-S/C) Responses of Investigator [ Time Frame: up to 12 weeks ]
  • Correlation of TAK-935 Concentration and Plasma 24S-hydroxycholesterol (24HC) Levels [ Time Frame: up to 12 weeks ]
  • Percent Change from Baseline in Care Clinical Global Impression of Change (CGI-C) Responses of Parent/Family [ Time Frame: up to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 15q Duplication Syndrome
  • CDKL5 Deficiency Disease
Intervention  ICMJE Drug: TAK-935
TAK-935 tablets or mini-tablets.
Study Arms  ICMJE Experimental: TAK-935 (OV935)
Treatment: 8 weeks dose optimization followed by 12 weeks maintenance period.
Intervention: Drug: TAK-935
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2018)
30
Actual Study Completion Date  ICMJE July 31, 2020
Actual Primary Completion Date July 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694275
Other Study ID Numbers  ICMJE TAK-935-18-002 (OV935)
U1111-1219-5787 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Ovid Therapeutics Inc.
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP