Condition category
Nervous System Diseases
Date applied
03/07/2012
Date assigned
03/07/2012
Last edited
16/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Epilepsy is a condition that affects the brain and causes repeated seizures. Antiepileptic drugs (AED) are the mainstay of treatment and may have to be taken for life. The ultimate goal of treatment is to maximise quality of life by eliminating seizures at drug doses that do not cause side effects. However, for many patients there is a necessary trade-off between effective seizure control and side effects, which can diminish quality of life. Over the past 20 years, a number of new AED drugs have become available and have been approved for NHS use on the basis of information from short-term studies, but these studies do not provide information about the longer term outcomes. The aim of this study is to compare the effectiveness and cost-effectiveness of the AEDs levetiracetam and zonisamide compared with the standard treatments for epilepsy (lamotrigine and valproate).

Who can participate?
Children aged 5 or older and adults with epilepsy

What does the study involve?
This study is essentially two studies run in parallel. Patients with untreated focal onset seizures (affecting a small part of the brain) are randomly allocated to be treated with either lamotrigine, levetiracetam or zonisamide. Patients with generalised onset seizures (affecting both halves of the brain) or seizures that are difficult to classify are randomly allocated to be treated with either levetiracetam or valproate.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Liverpool (UK)

When is the study starting and how long is it expected to run for?
August 2012 to February 2018

Who is funding the study?
NIHR Health Technology Assessment program (HTA) (UK)

Who is the main contact?
Silviya Balabanova
silviya.balabanova@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Silviya Balabanova

ORCID ID

Contact details

Molecular and Clinical Pharmacology Department
Clinical Sciences Centre
University of Liverpool
Lower Lane
Liverpool
L9 7LJ
United Kingdom
-
silviya.balabanova@liv.ac.uk

Additional identifiers

EudraCT number

2012-001884-64

ClinicalTrials.gov number

Protocol/serial number

12477

Study information

Scientific title

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)

Acronym

SANAD-II

Study hypothesis

SANAD-II is a phase IV multicentre pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments (lamotrigine and valproate) for epilepsy.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12477

Ethics approval

NRES Committee North West – Liverpool East, First MREC approval date 07/06/2012, ref: 12/NW/0361

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

SANAD-II will essentially be two randomised controlled trials run in parallel. Arm A of SANAD-II will compare lamotrigine, levetiracetam and zonisamide in patients with untreated focal onset seizures. Arm B of SANAD-II will compare levetiracetam and valproate in patients with generalised onset seizures or seizures that are difficult to classify. It will aim to accrue about 1510 patients (children aged 5 or older and adults) over a 3.5 year period and follow up will continue for a further two years (a maximum time a patient will receive randomised treatment is 5.5 years). There will be economy of scale given that the protocols and data structure are almost identical and that the same group of collaborators will be recruiting patients to both trials. There will be no competition for patients between Arm A and Arm B as the inclusion criteria are mutually exclusive. All treatments will be issued as per routine NHS.

Arm A: Patients randomised to receive lamotrigine, levetiracetam or zonisamide
Arm B: Patients randomised to receive levetiracetam or valproate
Trial interventions will follow the usual clinical practice

Intervention type

Drug

Phase

Not Applicable

Drug names

Lamotrigine, levetiracetam, zonisamide, valproate

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/08/2012

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 1510; UK Sample Size: 1510

Participant 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)

Recruitment start date

01/08/2012

Recruitment end date

01/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Liverpool
L9 7LJ
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Health Services Research
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment program (HTA) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes