Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy (Endymion)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635073
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE August 6, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE July 19, 2018
Estimated Primary Completion Date March 21, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Incidence of Adverse Events [ Time Frame: up to Week 108 ]
  • Change from Baseline in behavioral and adaptive functional measures using the Vineland Adaptive Behavior Scale (VABS) [ Time Frame: up to Week 108 ]
  • Change from Baseline in behavior measures using total scores and subscale scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for patients ≥6 years of age [ Time Frame: up to Week 108 ]
  • Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment categories 1,2,3,4, and 7 for patients ≥6 years of age [ Time Frame: up to Week 108 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Incidence of Adverse Events [ Time Frame: up to Week 108 ]
  • Incidence of potentially clinically significant clinical safety laboratory test [ Time Frame: up to Week 108 ]
  • Incidence of potentially clinically significant vital sign evaluation [ Time Frame: up to Week 108 ]
  • Incidence of potentially clinically significant weight evaluation [ Time Frame: up to Week 108 ]
  • Incidence of potentially clinically significant height/length evaluation [ Time Frame: up to Week 108 ]
  • Incidence of potentially clinically significant ECG evaluation [ Time Frame: up to Week 108 ]
  • The percentage of participants with changes from baseline in clinically significant standard safety laboratory values including hematology and serum chemistry [ Time Frame: up to Week 108 ]
  • The percentage of participants with changes from baseline in clinically significant vital sign measurements including blood pressure, pulse, body temperature, and respiratory rate [ Time Frame: up to Week 108 ]
  • Change from Baseline in clinically significant body weight [ Time Frame: up to Week 108 ]
  • The percentage of participants with changes in clinically significant 12-lead ECG findings [ Time Frame: up to Week 108 ]
  • Change from Baseline in behavioral and adaptive functional measures using the Vineland Adaptive Behavior Scale (VABS) [ Time Frame: up to Week 108 ]
  • Change from Baseline in behavior measures using total scores and subscale scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for patients ≥6 years of age [ Time Frame: up to Week 108 ]
  • Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment categories 1,2,3,4, and 7 for patients ≥6 years of age [ Time Frame: up to Week 108 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Change from Baseline in all seizure frequency [ Time Frame: up to Week 108 ]
  • Change from Baseline in mean drop seizure frequency [ Time Frame: up to Week 108 ]
  • Change from Baseline in mean convulsive [ Time Frame: up to Week 108 ]
  • Change from Baseline in mean motor seizure frequency [ Time Frame: up to Week 108 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy
Official Title  ICMJE A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy
Brief Summary The main purpose of this study is to investigate the long-term safety and tolerability of TAK-935/OV935 as an adjunctive therapy in patients with rare epilepsies.
Detailed Description

The drug being tested in this study is called TAK-935 (OV935). This global, open-label study will assess the safety and tolerability of TAK-935 for 2 years in patients who participated in previous short-term efficacy/safety studies of TAK-935. All patients will receive TAK-935 treatment.

Patients who rollover from previous blinded study will undergo up to 0 to 2 weeks of Dose Optimization Period (depending on the previous study) followed by 103-weeks of Maintenance Period. Patients who rollover from an open-label study will continue on their current dose for 103-weeks. There will be a 4-week safety follow-up after the last dose, including a 2-week dose tapering period.

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 Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder
Intervention  ICMJE Drug: TAK-935
TAK-935 tablets or mini-tablets.
Study Arms  ICMJE Experimental: TAK-935
Treatment: 0 to 2 Weeks Dose Optimization Period followed by 103 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
176
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2018)
165
Estimated Study Completion Date  ICMJE April 21, 2023
Estimated Primary Completion Date March 21, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Participants must have participated in a previous TAK-935 study and meet one of the following conditions:

  • Successfully completed a TAK-935 clinical study
  • In the opinion of the investigator, the participant has the potential to benefit from the administration of TAK-935

Exclusion Criteria:

  1. Clinically significant disease, that, in the investigator's opinion, precludes study participation
  2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving TAK-935)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ovid Call Center 646-661-7661 clinical@ovidrx.com
Listed Location Countries  ICMJE Australia,   Canada,   China,   Israel,   Poland,   Portugal,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03635073
Other Study ID Numbers  ICMJE TAK-935-18-001
U1111-1218-5515 ( Other Identifier: WHO )
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Ovid Therapeutics Inc.
Investigators  ICMJE Not Provided
PRS Account Takeda
Verification Date June 2020

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