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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 : April 16, 2019
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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


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.




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. Percent 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. Percent Change from Baseline in Care Clinical Global Impression of Change (CGI-C) Responses of Parent/Family [ Time Frame: up to 20 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 35 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. 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

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 clinical@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 Recruiting
Norcross, Georgia, United States, 30093
United States, Massachusetts
Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital Not yet 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 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

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03694275     History of Changes
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: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
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