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
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
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