Tuberous Sclerosis Complex

Aspirin

Epilepsy

Cognitive Decline

Skin Lesions

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

Department of Neurology, Peking Union Medical College Hospital

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

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

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)

Peking Union Medical College Hospital

Shijiazhuang Yiling Pharmaceutical Co. Ltd

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.

angiofibroma/seizures

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

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