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)

• ClinicalTrials.gov Identifier: NCT03635073
• Recruitment Status: Recruiting
• First Posted: August 17, 2018
• Last Update Posted: June 26, 2020
• Sponsor: Takeda
• Collaborator: Ovid Therapeutics Inc.
• Information provided by (Responsible Party): Takeda

Tracking Information

• First Submitted Date: August 6, 2018
• First Posted Date: August 17, 2018
• Last Update Posted Date: June 26, 2020
• Actual Study Start Date: July 19, 2018
• Estimated Primary Completion Date: March 21, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder

Intervention

Drug: TAK-935

TAK-935 tablets or mini-tablets.

Study Arms

Experimental: TAK-935

Treatment: 0 to 2 Weeks Dose Optimization Period followed by 103 weeks Maintenance Period.

Intervention: Drug: TAK-935

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 24, 2019): 176
• Original Estimated Enrollment (submitted: August 15, 2018): 165
• Estimated Study Completion Date: April 21, 2023
• Estimated Primary Completion Date: March 21, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 2 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ovid Call Center; 646-661-7661; clinical@ovidrx.com

• Listed Location Countries: Australia, Canada, China, Israel, Poland, Portugal, Spain, United States

Administrative Information

• NCT Number: NCT03635073
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Takeda
• Study Sponsor: Takeda
• Collaborators: Ovid Therapeutics Inc.
• Investigators: Not Provided
• PRS Account: Takeda
• Verification Date: June 2020