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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)

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ClinicalTrials.gov Identifier: NCT03635073
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder Drug: TAK-935 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : March 21, 2023
Estimated Study Completion Date : April 21, 2023


Arm Intervention/treatment
Experimental: TAK-935
Treatment: 0 to 2 Weeks Dose Optimization Period followed by 103 weeks Maintenance Period.
Drug: TAK-935
TAK-935 tablets or mini-tablets.




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: up to Week 108 ]
  2. Change from Baseline in behavioral and adaptive functional measures using the Vineland Adaptive Behavior Scale (VABS) [ Time Frame: up to Week 108 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Change from Baseline in all seizure frequency [ Time Frame: up to Week 108 ]
  2. Change from Baseline in mean drop seizure frequency [ Time Frame: up to Week 108 ]
  3. Change from Baseline in mean convulsive [ Time Frame: up to Week 108 ]
  4. Change from Baseline in mean motor seizure frequency [ Time Frame: up to Week 108 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT03635073


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03635073    
Other Study ID Numbers: TAK-935-18-001
U1111-1218-5515 ( Other Identifier: WHO )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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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:
soticlestat
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Myoclonic
Lennox Gastaut Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes
Genetic Diseases, Inborn