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 |
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Recruitment Status :
Recruiting
First Posted : August 17, 2018
Last Update Posted : June 26, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder | Drug: TAK-935 | Phase 2 |
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 (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 |
|---|---|
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Experimental: TAK-935
Treatment: 0 to 2 Weeks Dose Optimization Period followed by 103 weeks Maintenance Period.
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Drug: TAK-935
TAK-935 tablets or mini-tablets. |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- Clinically significant disease, that, in the investigator's opinion, precludes study participation
- 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)
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
| Contact: Ovid Call Center | 646-661-7661 | clinical@ovidrx.com |
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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: | June 26, 2020 |
| Last Verified: | June 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |