Evaluating Butylphthalide Capsules to Improve Cognitive Problems in Older Adults with Focal Epilepsy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of butylphthalide soft capsules for treating cognitive impairment in elderly patients with focal epilepsy. This trial focuses on patients aged 60 to 85 years who have mild to moderate cognitive impairment and have been diagnosed with focal epilepsy. The study addresses a significant need because current epilepsy treatments mainly control seizures but do not improve cognitive problems associated with epilepsy. Butylphthalide, a neuroprotective drug approved for stroke in China, may offer benefits for cognitive function through multiple protective mechanisms. Participants will be randomly assigned to receive either butylphthalide soft capsules 0.2g taken orally three times daily before meals or matching placebo capsules for 48 weeks. All participants will continue their stable anti-seizure medication during the study. The trial is double-blinded and placebo-controlled, and it will be conducted across multiple centers. Both study groups will follow the same dosing schedule while researchers monitor responses. During the study, participants will undergo regular cognitive tests including the Montreal Cognitive Assessment MoCA, Trail Making Tests, Digit Span tests, and Rey Auditory Verbal Learning Test. Researchers will also assess seizure frequency, daily functioning, and quality of life. Safety is monitored with laboratory tests and adverse event reporting throughout the 48-week treatment period. The main outcome is the change in MoCA score from baseline to 48 weeks, with secondary outcomes assessing various cognitive and functional measures and potential biomarkers.

Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy