Adjunctive Everolimus Treatment of Refractory Epilepsy

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Dependence, China
• Collaborators: Peking University; Shengjing Hospital
• Treatments: Everolimus

Criteria

Inclusion Criteria:

• Diagnosis of drug resistant epilepsy, with treatment of at least two approved anti-epileptic drugs (AEDs), and having at least one reported seizure per month during the 3-month baseline phase and no continuous 3-month seizure-free period.

• Diagnosis of focal epilepsy without secondary generalization.

• Treatment with a stable dose of AEDs that must have no drug interactions with everolimus (eg, valproic acid, topiramate, oxazepine, phenobarbital, phenytoin, and primidone) for at least 12 weeks before enrollment.

Exclusion Criteria:

• History of non-drug treatment for epilepsy, eg, vagus nerve stimulation (VNS), ketogenic diet, and epilepsy surgery.

• Severe dysfunction in kidney.

• With significant infectious, immunologic, or oncologic comorbidity at the time of enrollment.

• Currently taking or previously treated systemically with an mammilian target of rapamycin (mTOR) inhibitor.

• History of seizures secondary to drug abuse, psychogenic nonepileptic seizures, or an episode of status epilepticus within 1 year before enrollment.