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

• Status: Recruiting
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Shijiazhuang Pharmaceutical Group Co. Ltd.; Shijiazhuang Yiling Pharmaceutical Co. Ltd
• Treatments: Anticonvulsants; Aspirin

Criteria

Inclusion Criteria:

1. 6-30 years old TSC patients (by Gomez criteria)

2. more than 8 seizures occurred in the 4-week baseline time,with no continued seizure-free time of more than 10 days a month

3. 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

4. patients who had been treated with rapamycin should have been stopped for more than 3 months

5. vagus nerve stimulation (VNS) is allowed as a previous or current therapy and would maintain until the end of the trial

Exclusion Criteria:

1. Subependymal Giant Cell Astrocytoma and requires immediate surgery；

2. a history of intracranial surgery within 6 months;

3. epilepsy caused by improper use of drugs;

4. patients treated with aspirin had severe or intolerant side effects, including gastrointestinal ulcer, bleeding, aspirin allergy, and other conditions;

5. psychogenic seizures;

6. severe renal dysfunction and infection

7. pregnant women and lactating women

8. not regular follow-up

9. 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.