Status:
UNKNOWN
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Conditions:
Tuberous Sclerosis Complex
Aspirin
Eligibility:
All Genders
6-30 years
Phase:
PHASE2
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 effica...
Detailed Description
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 Kawasak...
Eligibility Criteria
Inclusion
- 6-30 years old TSC patients (by Gomez criteria)
- more than 8 seizures occurred in the 4-week baseline time,with no continued seizure-free time of more than 10 days a month
- more than two antiepileptic drugs (AED) had been administered but fail to control the situation; maintaining with 1 or more than 1 AEDS for over 2 months and intending to continue with the drugs
- patients who had been treated with rapamycin should have been stopped for more than 3 months
- vagus nerve stimulation (VNS) is allowed as a previous or current therapy and would maintain until the end of the trial
Exclusion
- Subependymal Giant Cell Astrocytoma and requires immediate surgery；
- a history of intracranial surgery within 6 months;
- epilepsy caused by improper use of drugs;
- patients treated with aspirin had severe or intolerant side effects, including gastrointestinal ulcer, bleeding, aspirin allergy, and other conditions;
- psychogenic seizures;
- severe renal dysfunction and infection
- pregnant women and lactating women
- not regular follow-up
- other: because when children and adolescents suffering from influenza or chickenpox, using aspirin may cause a rare life-threatening Reye syndrome (characterized with persistent vomiting）, should temporary withdrawal, medication needs to consult a physician before using again.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2021
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03356769
Start Date
November 20 2017
End Date
November 20 2021
Last Update
June 9 2020
Active Locations (1)
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1
Department of Neurology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005