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Phase 1b Study of DSP-0378: Evaluation of Safety, Pharmacokinetics, and Efficacy Following Single Oral Dose in Patients with Rare and Refractory Epilepsy

Phase 1b Study of DSP-0378

Endo Mika

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan

cr@sumitomo-pharma.co.jp

Product information center

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan

+81-120-034-389

cc@sumitomo-pharma.co.jp

Recruiting

Jan. 22, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Age between 18 and 65 years at the time of informed consent.
- Diagnosed with Benign Adult Familial Myoclonic Epilepsy (BAFME) and exhibiting cortical myoclonus in either upper limb.
- Receiving no more than three antiepileptic drugs (AEDs).
- The type, dosage, and regimen of AEDs have remained unchanged for at least 30 days prior to screening and are expected to remain unchanged from screening through post-observation.
- If receiving benzodiazepines (including as needed use), the type, dosage, and regimen have remained unchanged for at least 30 days prior to screening and are expected to remain unchanged from screening through post-observation.
- For women of childbearing potential and men with partners of childbearing potential: agree to practice abstinence as part of lifestyle or use appropriate and reliable contraception from informed consent until 30 days after the last dose.

- Presence or history of clinically significant or unstable cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematologic, respiratory, psychiatric disorders, or neurological disorders other than epilepsy, or judged by the investigator to be inappropriate for participation in this study.
- Pregnant, possibly pregnant, or breastfeeding.
- History of worsening myoclonus or epileptic seizures that could not be ruled out as being related to benzodiazepine use.
- Body weight <30 kg or >=80 kg at screening.

Both

Benign Adult Familial Myoclonic Epilepsy (BAFME)

A single oral dose of DSP-0378 (30 to 180 mg) will be administered under fasting conditions, following a minimum fasting period of at least 5 hours prior to dosing.

Safety (adverse events, vital signs, clinical laboratory tests, 12-lead electrocardiogram, Columbia-Suicide Severity Rating Scale [C-SSRS], Richmond Agitation-Sedation Scale [RASS], and neurological examination)

+81-75-751-3111

Dec. 26, 2025

No

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