Condition category
Signs and Symptoms
Date applied
11/01/2005
Date assigned
22/07/2005
Last edited
06/02/2015
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

Dr Charles Newton

ORCID ID

Contact details

Neurosciences Unit
Mecklenburgh Square
University College London
London
WC1N 2AP
United Kingdom
+44 (0)20 7837 7618
cnewton@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SSC 819

Study information

Scientific title

A randomised double-blind placebo-controlled trial of Fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies

Acronym

FOSCOM - FOSphenytoin in non-traumatic COMa

Study hypothesis

Seizures in acute encephalopathies are associated with neuro-cognitive impairment following recovery. Prevention of the seizures (which may manifest as convulsions, abnormal motor posturing or electrographic seizures) during the acute illness may improve the neuro-cognitive outcome.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Acute non-traumatic encephalopathies

Intervention

This is a double blind randomised controlled trial to evaluate the safety and efficacy of a single intramuscular (im) injection of Fosphenytoin, 20 mg Phenytoin equivalents/kg in children with acute non-traumatic encephalopathies, given at admission to prevent seizures and abnormal motor posturing during stay in hospital and neuro-cognitive deficits assessed at three and 24 months. The control intervention is a placebo of normal saline.

Intervention type

Drug

Phase

Not Applicable

Drug names

Fosphenytoin

Primary outcome measures

1. The proportion of patients with clinical or electrographic seizures after intervention
2. The proportion of patients with abnormal motor posturing after intervention
3. The proportion of patients with neuro-cognitive deficits three months after discharge   

Secondary outcome measures

1. Mortality in either group
2. Proportion of children who develop status epilepticus after intervention
3. Frequency and types of adverse events
4. Mean duration of seizures that occur after the intervention
5. Changes in cerebral blood flow velocity in the middle cerebral artery during seizure episodes
6. Time to regain full consciousness
7. Duration of hospitalisation
8. Neurocognitive deficits at 24 months

The sample of 500 (i.e. 250 in each arm) has a 90% power at 5% level of significance to detect the following changes after allowing for a 20% loss to follow up and death:
a. A 50% reduction (from 27 to 13.5%) in patients with at least one seizure lasting more than five minutes or more than three seizures of any duration
b. A 50% reduction (from 34 to 17%) in patients who will develop abnormal motor posturing
c. A 50% reduction in cognitive impairment from 24 to 12% as measured by Evoked Response Potentials (ERP).

An interim analysis is planned after 200 children have been recruited into the trial.

Overall trial start date

28/12/2004

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children who are unable to localise a painful stimulus 30 minutes after a seizure or correction of hypoglycaemia
2. Written informed consent from the parents or guardian
3. Age 9 months to 13 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Children with a history of epilepsy, significant developmental delay, cerebral palsy, or sickle cell disease
2. Children who would have received phenytoin for treatment of seizures before recruitment
3. Evidence of head trauma

Recruitment start date

28/12/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Kenya

Trial participating centre

University College London
London
WC1N 2AP
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Institute of Child Health
30 Guilford Street
London
WC1N1EH
United Kingdom

Sponsor type

University/education

Website

http://www.ich.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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