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

NCT03356769 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Aspirin

low-dose of aspirin, 5mg/Kg/d, once every day, 25mg per tablets

DRUG

AED

maintain the dosages and the drugs throughout the 3-month observation time

DRUG

Placebo

placebo, 5mg/Kg/d, once every day, 25mg per tablets

Sponsors & Collaborators

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Qing Liu, MD PhD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2021-11-20
Completion
2021-11-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356769 on ClinicalTrials.gov