Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy

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.

Conditions

• Focal Epilepsy
• Cognitive Impairment

Interventions

DRUG

Butylphthalide

Butylphthalide soft capsules (0.1g per capsule) manufactured by CSPC NBP Pharmaceutical Co., Ltd. Participants take 2 capsules (0.2g total) orally three times daily, 15-30 minutes before meals, for 48 weeks. This represents off-label use for cognitive impairment comorbid with epilepsy, as the drug is currently approved in China only for acute ischemic stroke treatment.

DRUG

Placebo

Matching placebo capsules identical in appearance, weight, and odor to butylphthalide soft capsules, manufactured by the same company following GMP standards. Participants take 2 capsules orally three times daily, 15-30 minutes before meals, for 48 weeks. Placebo contains starch and appropriate excipients.

Sponsors & Collaborators

• Taizhou Hospital

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• Affiliated Yueqing Hospital of Wenzhou Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Principal Investigators

• Huiqin Xu, MD · Department of Neurology, First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-12-31

Completion

2028-09-01

Countries

• China

Study Locations