A Phase 2 interventional study of Aspirin and AED in Tuberous Sclerosis Complex, Aspirin and Epilepsy, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
115 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.
This study's planned enrollment of 98 is above the median of 52 across 73 interventional studies indexed under Tuberous Sclerosis.
Browse Tuberous Sclerosis studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Aspirin 5mg/kg，maximum 300mg; once a day plus AEDS
Drug: Aspirin · Drug: AED
placebo 5mg/kg，maximum 300mg; once a day plus AEDS
Drug: AED · Drug: Placebo
low-dose of aspirin, 5mg/Kg/d, once every day, 25mg per tablets
Also known as: acetylsalicylic acid, enteric-coated aspirin tablets
maintain the dosages and the drugs throughout the 3-month observation time
Also known as: antiepileptic drugs
placebo, 5mg/Kg/d, once every day, 25mg per tablets
Also known as: Placebo tablets
Percentage of reduction in seizure frequency
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)
Time frame: Baseline phase (week 0); Observation phase week 1（±1 days）；Observation phase week 2（±2 days）；Observation phase week 4（±3 days）d；Observation phase week 8（±7 days）；Observation phase week 12（±14 days）
Total days of seizure free
Days of seizure free in a four week observation time
Time frame: Baseline, Week 0-4, Week 4-8, Week 8-12
A mild reduction in seizure frequency
At least 25% of median seizure frequency reduction comparing with those in the baseline
Time frame: baseline, Week 12
Changes of epileptic discharges in electroencephalogram
Epileptic discharge on 2-hour video electroencephalogram in frequency detected at the same lead(s) comparing with baseline
Time frame: Baseline, Week 12
Improvement of facial angiofibromas
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)
Time frame: Baseline, Week 4, Week 8, Week 12
Changes of cognitive condition
Raven standard reasoning test
Time frame: Baseline, Week 12
Subjective evaluation of treatment-response condition
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
Time frame: Baseline, Week 12
genetic analysis
genotype-phenotype correlation; evaluated by severity of symptoms and treatment effects
Time frame: Baseline, Week 12
treatment-response annotation
Charts of seizure frequency reduction on different treatment time points would show the fluctuations of treatment effects (eg. the effective time)
Time frame: Baseline phase (week 0); Observation phase week 1（±1 days）；Observation phase week 2（±2 days）；Observation phase week 4（±3 days）d；Observation phase week 8（±7 days）；Observation phase week 12（±14 days）
Plan to share: Undecided
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
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