A study of Standard and New Antiepileptic Drugs – SANAD-II.

Phase 1

• Conditions: Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001884-64-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1510

Inclusion Criteria

Patients with the following characteristics will be eligible for inclusion in the trial:
a.Aged 5 years or older
b.Two or more spontaneous seizures that require antiepileptic drug treatment
c.Untreated and not previously treated with antiepileptic drugs
d.Antiepileptic drug monotherapy considered the most appropriate option
e.Willing to provide consent (patients parent/legal representative willing to give consent where the patient is aged under 16 years of age)

Are the trial subjects under 18? yes
Number of subjects for this age range: 353
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1042
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

Exclusion Criteria

Patients with the following characteristics will be excluded from the trial:
a.Provoked seizures (e.g. alcohol)
b.Acute symptomatic seizures (e.g. acute brain haemorrhage or brain injury)
c.Currently treated with antiepileptic drugs
d.Progressive neurological disease (e.g. known brain tumour)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified