Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03356769
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2017-11-02
Brief Title:
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
There is no optional treatment for patients with tuberous sclerosis complex TSC and refractory epilepsyThe 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 512-897 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 monthsTSC patients aged 6-30 years old would be recruited with refractory seizures and randomly assigned to two groups aspirin and antiepileptic drugsAEDS 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 monthlyThe 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 analysisThe study is designed as a placebo-controlled randomized blinded evaluation trial
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 monthsTSC patients aged 6-30 years old would be recruited with refractory seizures and randomly assigned to two groups aspirin and antiepileptic drugsAEDS 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 monthlyThe 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 analysisThe study is designed as a placebo-controlled randomized blinded evaluation trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None