Epilepsy Clinical Trial
Official title:
A Placebo-controlled Study of Efficacy & Safety of Aspirin as an add-on Treatment in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Seizures
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.
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