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

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Brief Title

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

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

Brief 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.
    

Detailed 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of reduction in seizure frequency

Secondary Outcome

 Total days of seizure free

Condition

Tuberous Sclerosis Complex

Intervention

Aspirin

Study Arms / Comparison Groups

 experimental:asprin & AEDS
Description:  Aspirin 5mg/kg,maximum 300mg; once a day plus AEDS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

98

Start Date

November 20, 2017

Completion Date

November 20, 2021

Primary Completion Date

November 20, 2021

Eligibility 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.
      

Gender

All

Ages

6 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Qing Liu, MD PhD, 133-6630-5331, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03356769

Organization ID

JS-1425


Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital

Collaborators

 Shijiazhuang Yiling Pharmaceutical Co. Ltd

Study Sponsor

Qing Liu, MD PhD, Principal Investigator, Peking Union Medical College Hospital


Verification Date

September 2019