Trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs

Not Applicable

Completed

• Conditions: Topic: Medicines for Children Research Network, Neurological; Subtopic: All Diagnoses, Neurological (all Subtopics); Disease: Nervous system disorders; Nervous System Diseases; Epilepsy

• Registration Number: ISRCTN30294119
• Lead Sponsor: niversity of Liverpool (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-03
• Study Completion: 2019-11-30
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1510

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to 12 month remission from seizures. This is a time to event outcome, measured during the entirity of follow-up.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adverse events at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years<br> 2. Quality of Life (QOL) outcomes at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years<br> 3. Time to 24 month remission. This is a time to event outcome, measured during the entirity of follow-up<br> 4. Time to first seizure. This is a time to event outcome, measured during the entirity of follow-up<br> 5. Time to treatment failure due to inadequate seizure control. This is a time to event outcome, measured during the entirity of follow-up<br> 6. Time to treatment failure due to unacceptable adverse events. This is a time to event outcome, measured during the entirity of follow-up<br> 7. Time to treatment failure. This is a time to event outcome, measured during the entirity of follow-up<br>