Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex

Phase

Condition

Epilepsy

Neurofibromatosis

Mental Disability

Treatment

N/A

Clinical Study ID

NCT03356769

JS-1425

Ages 6-30
All Genders

Study Summary

There had been much evidence in aspirin controlling tumorous conditions conducted by basic researches, especially through mammilian target of rapamycin (mTOR) pathway. The investigator observed efficacy of aspirin in the treatment of tuberous sclerosis complex (TSC) in one child who got Kawasaki disease and in the addition four TSC patients with epilepsy. The investigator intend to evaluate whether aspirin would be an effective add-on treatment in TSC patients with refractory seizures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

6-30 years old TSC patients (by Gomez criteria)
more than 8 seizures occurred in the 4-week baseline time,with no continuedseizure-free time of more than 10 days a month
more than two antiepileptic drugs (AED) had been administered but fail to control thesituation; maintaining with 1 or more than 1 AEDS for over 2 months and intending tocontinue with the drugs
patients who had been treated with rapamycin should have been stopped for more than 3months
vagus nerve stimulation (VNS) is allowed as a previous or current therapy and wouldmaintain until the end of the trial

Exclusion

Exclusion Criteria:

Subependymal Giant Cell Astrocytoma and requires immediate surgery；
a history of intracranial surgery within 6 months;
epilepsy caused by improper use of drugs;
patients treated with aspirin had severe or intolerant side effects, includinggastrointestinal ulcer, bleeding, aspirin allergy, and other conditions;
psychogenic seizures;
severe renal dysfunction and infection
pregnant women and lactating women
not regular follow-up
other: because when children and adolescents suffering from influenza or chickenpox,using aspirin may cause a rare life-threatening Reye syndrome (characterized withpersistent vomiting）, should temporary withdrawal, medication needs to consult aphysician before using again.

Study Design

November 20, 2017

November 20, 2021

Study Description

There is no optional treatment for patients with tuberous sclerosis complex (TSC) and refractory epilepsy.The investigator observed efficacy of aspirin in the treatment of in one child who got Kawasaki disease. Subsequent adjunctive aspirin therapy in four patients yielded a reducted frequency of seizure for 51.2-89.7%. The investigator intend to evaluate whether aspirin would be an effective add-on treatment in TSC patients with refractory seizures.

Refractory epilepsy was defined as more than 8 times of epileptic events in 4 weeks at baseline, and had been given more than two antiepileptic drugs maintaining for more than 3 months.TSC patients aged 6-30 years' old would be recruited with refractory seizures and randomly assigned to two groups, aspirin and antiepileptic drugs(AEDS) group and placebo-AEDS group after written informed consent be obtained. Patients and their guardians would be instructed to record their own seizure diary on the epileptic events and report monthly.The primary outcome would be reduction of seizure frequency (measured by average seizure frequency and response rate). The secondary outcome would include seizure-free days, seizure-free rates, changes in EEG, changes of facial angiofibromas, and exposure-response relationship analysis.The study is designed as a placebo-controlled, randomized, blinded evaluation trial.

Connect with a study center

Department of Neurology, Peking Union Medical College Hospital
Beijing, Beijing 100005
China
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.