Clinical trial · Interventional
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex
A Placebo-controlled Study of Efficacy & Safety of Aspirin as an add-on Treatment in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Seizures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspirin | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Epilepsy | — | UNRESOLVED | — |
| Skin Lesions | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AED | Drug | — | UNRESOLVED |
| Aspirin | Drug | Aspirin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental:asprin & AEDS
- description
- Aspirin 5mg/kg,maximum 300mg; once a day plus AEDS
- interventionNames
- Drug: Aspirin
- Drug: AED
- type
- PLACEBO_COMPARATOR
- label
- control: placebo & AEDS
- description
- placebo 5mg/kg,maximum 300mg; once a day plus AEDS
- interventionNames
- Drug: AED
- Drug: Placebo
Primary outcomes (1)
- measure
- Percentage of reduction in seizure frequency
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDFranz DN, Leonard J, Tudor C, Chuck G, Care M, Sethuraman G, Dinopoulos A, Thomas G, Crone KR. Rapamycin causes regression of astrocytomas in tuberous sclerosis complex. Ann Neurol. 2006 Mar;59(3):490-8. doi: 10.1002/ana.20784. PMID 16453317
- BACKGROUNDKrueger DA, Care MM, Holland K, Agricola K, Tudor C, Mangeshkar P, Wilson KA, Byars A, Sahmoud T, Franz DN. Everolimus for subependymal giant-cell astrocytomas in tuberous sclerosis. N Engl J Med. 2010 Nov 4;363(19):1801-11. doi: 10.1056/NEJMoa1001671. PMID 21047224
- BACKGROUNDDin FV, Valanciute A, Houde VP, Zibrova D, Green KA, Sakamoto K, Alessi DR, Dunlop MG. Aspirin inhibits mTOR signaling, activates AMP-activated protein kinase, and induces autophagy in colorectal cancer cells. Gastroenterology. 2012 Jun;142(7):1504-15.e3. doi: 10.1053/j.gastro.2012.02.050. Epub 2012 Mar 6. PMID 22406476
- BACKGROUNDChen CT, Du Y, Yamaguchi H, Hsu JM, Kuo HP, Hortobagyi GN, Hung MC. Targeting the IKKbeta/mTOR/VEGF signaling pathway as a potential therapeutic strategy for obesity-related breast cancer. Mol Cancer Ther. 2012 Oct;11(10):2212-21. doi: 10.1158/1535-7163.MCT-12-0180. Epub 2012 Jul 23. PMID 22826466
- BACKGROUNDNorthrup H, Krueger DA; International Tuberous Sclerosis Complex Consensus Group. Tuberous sclerosis complex diagnostic criteria update: recommendations of the 2012 Iinternational Tuberous Sclerosis Complex Consensus Conference. Pediatr Neurol. 2013 Oct;49(4):243-54. doi: 10.1016/j.pediatrneurol.2013.08.001. PMID 24053982
- BACKGROUNDOverwater IE, Rietman AB, Bindels-de Heus K, Looman CW, Rizopoulos D, Sibindi TM, Cherian PJ, Jansen FE, Moll HA, Elgersma Y, de Wit MC. Sirolimus for epilepsy in children with tuberous sclerosis complex: A randomized controlled trial. Neurology. 2016 Sep 6;87(10):1011-8. doi: 10.1212/WNL.0000000000003077. Epub 2016 Aug 10. PMID 27511181