Aspirin Clinical Trial - Aspirin as an add-on Treatment of Refractory

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Kawasaki disease. Subsequent adjunctive aspirin therapy in four patients yielded a reducted frequency of seizure for 51.2-89.7%. 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 months.TSC patients aged 6-30 years' old would be recruited with refractory seizures and randomly assigned to two groups, aspirin and antiepileptic drugs(AEDS) 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 monthly.The 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 analysis.The study is designed as a placebo-controlled, randomized, blinded evaluation trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03356769
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Qing Liu, MD PhD
Phone	133-6630-5331
Email	drliuqing@126.com
Status	Recruiting
Phase	Phase 2
Start date	November 20, 2017
Completion date	November 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04595513` - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants	Phase 1/Phase 2
Completed	`NCT02909387` - Adapting Project UPLIFT for Blacks in Georgia	N/A
Completed	`NCT05552924` - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients	N/A
Terminated	`NCT01668654` - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS	Phase 3
Not yet recruiting	`NCT05068323` - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients	N/A
Completed	`NCT03994718` - Creative Arts II Study	N/A
Recruiting	`NCT04076449` - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed	`NCT00782249` - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Recruiting	`NCT05101161` - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes	N/A
Active, not recruiting	`NCT06034353` - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients	N/A
Recruiting	`NCT05769933` - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting	`NCT06408428` - Glioma Intraoperative MicroElectroCorticoGraphy	N/A
Not yet recruiting	`NCT05559060` - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed	`NCT02952456` - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed	`NCT02646631` - Behavioral and Educational Tools to Improve Epilepsy Care	N/A
Completed	`NCT02977208` - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use	Phase 4
Recruiting	`NCT02539134` - TAK-935 Multiple Rising Dose Study in Healthy Participants	Phase 1
Terminated	`NCT02757547` - Transcranial Magnetic Stimulation for Epilepsy	N/A
Completed	`NCT02491073` - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms