Safety and Efficacy of Butylphthalide Soft Capsules for Cognitive Impairment Comorbid With Focal Epilepsy in Elderly Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of butylphthalide soft capsules for treating cognitive impairment in elderly patients with focal epilepsy. Study Population: 220 elderly patients (60-85 years) with focal epilepsy and mild to moderate cognitive impairment (Montreal Cognitive Assessment score 18-25). Intervention: Participants will be randomly assigned 1:1 to receive either butylphthalide soft capsules (0.2g three times daily) or matching placebo for 48 weeks, while continuing their stable anti-seizure medication regimen. Primary Outcome: Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 48 weeks. Secondary Outcomes: Changes in neuropsychological tests (Trail Making Test, Digit Span, Rey Auditory Verbal Learning Test), seizure control measures, functional status (Activities of Daily Living, Quality of Life in Epilepsy), and exploratory neurobiological markers. This study addresses an important unmet medical need, as current epilepsy treatments focus primarily on seizure control but lack effective interventions for epilepsy-associated cognitive impairment. Butylphthalide, a neuroprotective agent approved for acute ischemic stroke in China, has shown promise in other cognitive disorders and may benefit this patient population through its multiple neuroprotective mechanisms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 60-85 years (inclusive)

• Diagnosed with focal epilepsy according to ILAE 2025 latest classification standards, with disease duration ≥2 years

• Currently receiving stable anti-seizure medication (ASM) treatment for ≥3 months, with good seizure control (monthly seizure frequency ≤4 times in the past 3 months)

• Cognitive impairment: Montreal Cognitive Assessment (MoCA) score 18-25 points (inclusive)

• Basic Chinese language comprehension and expression ability, able to cooperate with neuropsychological testing

• Voluntary participation and signed informed consent

Locations
Other Locations
China
First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Huiqin Xu, MD
xuhuiqin@wmu.edu.cn
+86-13858806368
Backup
Jiahe Lin, PhD
linjiahe@wmu.edu.cn
+86-13587572321
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 220
Treatments
Experimental: Butylphthalide Group
Participants receive butylphthalide soft capsules 0.2g (two 0.1g capsules) orally three times daily before meals for 48 weeks, while continuing their stable anti-seizure medication regimen.
Placebo_comparator: Placebo Group
Participants receive matching placebo capsules orally three times daily before meals for 48 weeks, while continuing their stable anti-seizure medication regimen. Placebo capsules are identical in appearance, weight, and odor to butylphthalide capsules.
Related Therapeutic Areas
Sponsors
Collaborators: The Third Affiliated Hospital of Wenzhou Medical University, Affiliated Yueqing Hospital of Wenzhou Medical University, Lishui Country People's Hospital, Taizhou Central Hospital affiliated to Taizhou University
Leads: First Affiliated Hospital of Wenzhou Medical University

This content was sourced from clinicaltrials.gov