A Phase 1 interventional study of OPC-214870 and Placebo in Epilepsy, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Treatment
Despite availability of several antiepileptic drugs (AEDs), in one-third of patients, epilepsy remains uncontrolled with AEDs. There is a need to develop new approaches to improve the existing medications to relieve patients' epilepsy, and OPC-214870 is being studied for this purpose.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose; up to 400 mg capsule; adaptive dosage determined by initial dosing from cohort 1.Potential for a matching placebo dose to be administered.
Drug: OPC-214870 · Other: Placebo
Single dose; potential for a matching OPC-214870 dose to be administered.
Drug: OPC-214870 · Other: Placebo
Tablet(s)
Tablet(s)
Change in Standardized Photosensitivity Range (SPR)
OPC-214870 in comparison to placebo
Time frame: Up to 3 days
Onset and duration of SPR
OPC-214870 in comparison to placebo
Time frame: Up to 3 days
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Development & Commercialization, Inc.