Epilepsy Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | November 20, 2021 |
Est. primary completion date | November 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 30 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology, Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Shijiazhuang Yiling Pharmaceutical Co. Ltd |
China,
Chen CT, Du Y, Yamaguchi H, Hsu JM, Kuo HP, Hortobagyi GN, Hung MC. Targeting the IKKß/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. — View Citation
Din 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. — View Citation
Franz 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. — View Citation
Krueger 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. — View Citation
Northrup 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. — View Citation
Overwater 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | genetic analysis | genotype-phenotype correlation; evaluated by severity of symptoms and treatment effects | Baseline, Week 12 | |
Other | treatment-response annotation | Charts of seizure frequency reduction on different treatment time points would show the fluctuations of treatment effects (eg. the effective time) | 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) | |
Primary | 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) |
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) | |
Secondary | Total days of seizure free | Days of seizure free in a four week observation time | Baseline, Week 0-4, Week 4-8, Week 8-12 | |
Secondary | A mild reduction in seizure frequency | At least 25% of median seizure frequency reduction comparing with those in the baseline | baseline, Week 12 | |
Secondary | Changes of epileptic discharges in electroencephalogram | Epileptic discharge on 2-hour video electroencephalogram in frequency detected at the same lead(s) comparing with baseline | Baseline, Week 12 | |
Secondary | 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) | Baseline, Week 4, Week 8, Week 12 | |
Secondary | Changes of cognitive condition | Raven standard reasoning test | Baseline, Week 12 | |
Secondary | 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 | Baseline, Week 12 |
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