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Clinical Trials/ISRCTN30294119
ISRCTN30294119
Completed
未知

A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs (SANAD-II)

niversity of Liverpool (UK)0 sites1,510 target enrollmentJuly 3, 2012
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ConditionsTopic: Medicines for Children Research Network, NeurologicalSubtopic: All Diagnoses, Neurological (all Subtopics)Disease: Nervous system disordersNervous System DiseasesEpilepsy

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Medicines for Children Research Network, Neurological
Sponsor
niversity of Liverpool (UK)
Enrollment
1510
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32847927/ protocol (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33838757/ results for newly diagnosed focal epilepsy (added 13/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33838758/ results for newly diagnosed generalised and unclassifiable epilepsy (added 13/04/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34225782/ sub study on methods (added 07/07/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34931602/ HTA report (added 22/12/2021)

Registry
who.int
Start Date
July 3, 2012
End Date
November 30, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Liverpool (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Male and female aged 5 years or older
  • •2\. Two or more spontaneous seizures that require antiepileptic drug treatment
  • •3\. Untreated and not previously treated with antiepileptic drugs
  • •4\. Antiepileptic drug monotherapy considered the most appropriate option
  • •5\. Willing to provide consent (patients parent/legal representative willing to give consent where the patient is aged under 16 years of age)

Exclusion Criteria

  • •1\. Provoked seizures (e.g. alcohol)
  • •2\. Acute symptomatic seizures (e.g. acute brain haemorrhage or brain injury)
  • •3\. Currently treated with antiepileptic drugs
  • •4\. Progressive neurological disease (e.g. known brain tumour)

Outcomes

Primary Outcomes

Not specified

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