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

• Status: Recruiting
• Trial end date: 2023-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Ovid Therapeutics

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)