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Aspirin 5mg/kg，maximum 300mg; once a day plus AEDS

placebo 5mg/kg，maximum 300mg; once a day plus AEDS

low-dose of aspirin, 5mg/Kg/d, once every day, 25mg per tablets

maintain the dosages and the drugs throughout the 3-month observation time

placebo, 5mg/Kg/d, once every day, 25mg per tablets

Placebo

Qing Liu, MD PhD

Hui Xu, MD

Qing Liu, MD, PhD

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.

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.

Patients, investigators, site personnel, and the sponsor's study team were masked to treatment allocation, but allocation was not concealed from personnel in charge of drug supply, and implementation of the randomisation list. The Data Safety Monitoring Board (DSMB) independent statistician and programmer were semi-blind to treatment allocation at the time of DSMB meetings.

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

A Placebo-controlled Study of Efficacy & Safety of Aspirin as an add-on Treatment in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Seizures

genotype-phenotype correlation; evaluated by severity of symptoms and treatment effects

Charts of seizure frequency reduction on different treatment time points would show the fluctuations of treatment effects (eg. the effective time)

Estimated by median percentage of seizure frequency reduction and response rate comparing each group with the baseline; response rate is defined as more than 50% of reduction in seizure frequency.

The seizure diary of individual participants would be recorded every day during the trial time by the participants and their guardians. The correct way of recording will be guided by investigator specialized in epileptic disease with discrimination of real or false seizure events.

•seizure information was known within the same period of time (baseline or maintenance phase)

Days of seizure free in a four week observation time

At least 25% of median seizure frequency reduction comparing with those in the baseline

Epileptic discharge on 2-hour video electroencephalogram in frequency detected at the same lead(s) comparing with baseline

We observed improvement of facial lesions concurrent with seizure control, in the size, color and number of facial angiofibromas. The improvement will be estimated by Physician's Global Assessement Overall Score (PGA, 7-grade:more than -25%, -25% to 25%, 25-50%, 50-75%, 75%-100%, 100% improvement)

evaluated by physician/Caregiver who is familial with the patient with Physician's Global Assessement Overall Score (PGA, 7-grade:more than -25%, -25% to 25%, 25-50%, 50-75%, 75%-100%, 100% improvement ) and a two-page age-specific questionaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex	NCT03356769	Tuberous Sclero... Aspirin Epilepsy Cognitive Decli... Skin Lesions	Aspirin AED Placebo	6 Years - 30 Years	Peking Union Medical College Hospital
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex	NCT03356769	Tuberous Sclero... Aspirin Epilepsy Cognitive Decli... Skin Lesions	Aspirin AED Placebo	6 Years - 30 Years	Peking Union Medical College Hospital

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