Condition category
Nervous System Diseases
Date applied
07/07/2007
Date assigned
17/07/2007
Last edited
27/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Charles Newton

ORCID ID

Contact details

P.O. Box 230
Kilifi
80108
Kenya
cnewton@kilifi.kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KEMRI SCC 786

Study information

Scientific title

Acronym

AEPEP

Study hypothesis

To compare the frequency of side effects of phenobarbitone to those of phenytoin as first line treatment of active convulsive epilepsy.

Ethics approval

The Kemri/National Ethical Review Committee reviewed the proposal, and permission was granted on 21st June 2007 (ref: SSC 786).

Study design

Open label randomised trial of phenobarbitone versus phenytoin

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Epilepsy

Intervention

Phenobarbitone versus phenytoin, in which the assessor is blinded to the treatment allocation and patient is given information on the side effects of both anti-epileptic drugs together, but is not aware which side effects is attributed to which drug.

Treatment:
The following regimens for the drugs will be used:

Phenobarbitone: adults will be started on 60 mg daily orally in the evening, increasing to 120 mg daily after two weeks. Thereafter the dose will be titrated according to the response and side effects. If seizures are not controlled (greater than one per week) by six months after enrolling into the trial, the subject will be started on phenytoin.

Phenytoin: adults will be started on 50 mg daily, increasing to 100 mg daily (in two doses one in the morning and one in the evening). Thereafter the dose will be titrated according to the response and side effects. If seizures are not controlled (greater than one per week) by six months after enrolling into the trial, the subject will be started on phenobarbitone.

If both drugs prove to be ineffective, i.e., continued seizures after substitution with the other study drug then the subject will be started on dual therapy.

Monitoring:
All subjects will be seen a month after enrolment into the study, when they will be assessed by a clinician and the dosage of the drug adjusted according to clinical response and side effects. Blood and saliva samples will be taken for concentrations of the Antiepileptic Drug (AED), but the results will only be available at the subsequent visit.

Thereafter subjects will be seen at 3 months, 6 months and 12 months after starting treatment. At each visit, the subjects will be seen by a fieldworker (blinded to the treatment group), who will administer a Quality Of Life (QOL) questionnaire. Thereafter the subject will be seen by a clinician who will manage the epilepsy according to standard medical practice.

Subjects will also be asked to bring in the bottle of tablets so that they can be counted, and the excess tablets will be used to aid in estimation of compliance. Furthermore subjects will be visited at home by a designated fieldworker (maximum of 14 visits per day) to promote adherence.

Intervention type

Drug

Phase

Not Specified

Drug names

Phenobarbitone, phenytoin

Primary outcome measures

Frequency of side effects.

Secondary outcome measures

1. Time to next seizure after starting treatment using an epilepsy history questionnaire
2. Seizure frequency: frequency of seizures will be monitored using seizure calendars, which the subjects will be educated on keeping
3. Compliance with drugs: drug compliance will be assessed by direct measurement of drug levels in blood at the initial contact and at 12 months; and using saliva samples at the end of 1, 3, 6 and 12 months. This will be reinforced by tablet counting and information elicited from patients/caregivers
4. Quality of life measure as developed for this proposal
5. Cognitive effects: subjects will have a culturally appropriate test of cognitive function performed at 6 months and 1 and 3 years afterwards

Overall trial start date

09/07/2007

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Adults (greater than 17 years) with active epilepsy, i.e. two or more seizures within the last year and the following seizure types:
1. Tonic-clonic
2. Partial becoming generalised
3. Partial motor

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

1. Subjects who have received antiepileptic drugs in the past
2. Subjects with absence, myoclonic or atonic seizures
3. Subjects with progressive neurological disease
4. Subjects with severe learning difficulties
5. Less than 18 years old

Recruitment start date

09/07/2007

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Kenya

Trial participating centre

P.O. Box 230
Kilifi
80108
Kenya

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
tlang@kilifi.kemri-wellcome.org

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 077092)

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