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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001884-64-GB

Enrollment

1510

Registered

2012-05-09

Start date

2012-06-07

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Product Name: Sodium Valproate Pharmaceutical Form: Tablet INN or Proposed INN: Sodium Valproate Trade Name: Lamictal Product Name: Lamotrigine Pharmaceutical Form: Tablet INN or Proposed INN: Lamotr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Arm A - To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. Arm B - To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify. ;Secondary Objective: Arm A & B • Compare quality of life outcomes of initiating standard or new AEDs • Examine the development and evolution of quality of life impairments in patients with newly treated epilepsy ;Primary end point(s): Time to 12 month remission - measured using data recorded in participant seizure diaries and seizure data collected at all follow up visits.;Timepoint(s) of evaluation of this end point: The timepoint of evaluation of the primary endpoint is at minimum 12 months.	—

Measure

Time frame

Main Objective: Arm A - To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. Arm B - To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify. ;Secondary Objective: Arm A & B • Compare quality of life outcomes of initiating standard or new AEDs • Examine the development and evolution of quality of life impairments in patients with newly treated epilepsy ;Primary end point(s): Time to 12 month remission - measured using data recorded in participant seizure diaries and seizure data collected at all follow up visits.;Timepoint(s) of evaluation of this end point: The timepoint of evaluation of the primary endpoint is at minimum 12 months.

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Secondary

Measure	Time frame
Secondary end point(s): • Time to treatment failure* • Time to treatment failure due to inadequate seizure control* • Time to treatment failure due to unacceptable adverse events* • Time to first seizure* • Time to 24 month remission* • Adverse events* • Quality Of Life (QOL)* • Health economic outcomes* * Measured using information provided by the patient and clinicians;Timepoint(s) of evaluation of this end point: The timepoints of evaluation of the secondary endpoints is at every other follow up visit.	—

Measure

Time frame

Secondary end point(s): • Time to treatment failure* • Time to treatment failure due to inadequate seizure control* • Time to treatment failure due to unacceptable adverse events* • Time to first seizure* • Time to 24 month remission* • Adverse events* • Quality Of Life (QOL)* • Health economic outcomes* * Measured using information provided by the patient and clinicians;Timepoint(s) of evaluation of this end point: The timepoints of evaluation of the secondary endpoints is at every other follow up visit.

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Countries

United Kingdom

Contacts

Public ContactLindsay Carter

University of Liverpool

lindsay.carter@liv.ac.uk0151 794 8722

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026