Epilepsy MedDRA version: 17.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Carbamazepine
Product Name: Carbamazepine
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Carbamazepine
CAS Number: 298-46-4
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 3 months and 24 months of age (not beyond second birthday at baseline) 2. Diagnosis of epilepsy confirmed 3. At least an average of 7 seizures/week in baseline period 4. Failed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids. 5. Children with written informed consent from parent/guardian Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Age 24 months of age 2. No secure diagnosis of epilepsy 3. < 7 seizures/week on average in baseline period 4. Trial of < 2 AEDs 5. Continues on corticosteroids in previous 3 months prior to randomisation 6. Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline. 7. Progressive neurological disease 8. Severe gastroesophageal reflux 9. Previous treatment with the ketogenic diet 10. Concurrent participation in another clinical trial of an investigational medicinal product. 11. Patients who are prescribed AEDs not listed in the trial IMPs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness on seizure control of the ketogenic diet (KD) compared to further anti-epileptic drug (AED) treatment in children with epilepsy aged 3 months to 2 years who have failed to respond to two or more AEDs. Research question: Are there clear benefits in terms of seizure control in infants with continued seizures, despite two AEDs, treated with a KD as compared to a similar control group who are treated with a further AED?;Secondary Objective: Is the presence of medium chain fatty acids in the context of use of the ketogenic diet associated with enhanced mitochondrial function and seizure control in children under two years of age?;Primary end point(s): Number of seizures experienced during weeks 6 - 8.;Timepoint(s) of evaluation of this end point: 8 weeks after starting treatment/all patients: Clinical review including neurological examination, weight, length and head circumference, and documentation of seizure frequency (from seizure diaries). Completion of side effect/tolerability questionnaire, blood investigations (FBC, U&Es, Glucose, LFTs, plasma bicarbonate, calcium, magnesium, phosphate, zinc, selenium, acylcarnitine profile, cholesterol, triglycerides, urate, non-esterified fatty acids, blood ketones, free fatty acids) and urine calcium/creatinine ratio. Administration of the Infant Toddler Quality of Life Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine whether the presence of medium chain fatty acids in the context of use of the ketogenic diet is associated with enhanced mitochondrial function and seizure control in children under two years of age. To determine retention, quality of life and neurodevelopmental outcome at 12 months. ;Timepoint(s) of evaluation of this end point: At 8 weeks: The blood samples to evaluate the plasma profiles of medium chain fatty acids and for the assessment of mitochondrial function (respiratory chain enzymes) and enrichment (citrate synthase) will be processed at the Chemical Pathology Department at UCL. Final assessment (12 months after start of treatment period, all patients): This will include clinical evaluation to include seizure frequency, medication, ketogenic diet or not, quality of life questionnaire and Vineland adaptive questionnaire as well as height, weight and head circumference. Review of adverse events and concomitant medication. Blood investigations and urine calcium/creatinine ratio. Compliance with KD intervention manual and protocol will be reviewed. | — |
Countries
United Kingdom
Contacts
Public ContactHelen Cross
UCL - Institute of Child Health
Outcome results
None listed