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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2

Conditions

Skin Lesions
Tuberous Sclerosis Complex
Epilepsy
Cognitive Decline
Aspirin

Treatments

Drug: AED
Drug: Aspirin
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03356769
JS-1425

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 estimated patients

Sex

All

Ages

6 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

98 participants in 2 patient groups, including a placebo group

experimental:asprin & AEDS
Experimental group
Description:
Aspirin 5mg/kg,maximum 300mg; once a day plus AEDS
Treatment:
Drug: Aspirin
Drug: AED
control: placebo & AEDS
Placebo Comparator group
Description:
placebo 5mg/kg,maximum 300mg; once a day plus AEDS
Treatment:
Drug: Placebo
Drug: AED

Trial contacts and locations

1

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Central trial contact

Qing Liu, MD PhD; Hui Xu, MD

Data sourced from clinicaltrials.gov

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