We are studying a population of children with refractory epilepsy. MedDRA version: 14.1 Level: LLT Classification code 10053551 Term: Intractable epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: PHENOBARBITAL
Pharmaceutical Form: Tablet
INN or Proposed INN: Phenobarbital
Other descriptive name: Phenobarbital
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
UCL-INSTITUTE OF CHILD HEALTH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any child beteen 6-21 years with intractable epilepsy and on polytherapy for control of epilepsy Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Any child beteen 6-21 years with intractable epilepsy and on polytherapy for control of epilepsy Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Child with progressive neurological condition ;Exclusion criteria: Child with progressive neurological condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively determine the effect of reducing Anti Epileptic drug load on QOL and seizure control in children with refractory epilepsy who are on Anti epileptic drug polytherapy;Secondary Objective: ;Primary end point(s): The trial will be said to have ended once the last enrolled patient completes the second assessment also known as the follow up assessment for the purpose of this study.;Main Objective: To prospectively determine the effect of reducing Anti Epileptic drug load on QOL and seizure control in children with refractory epilepsy who are on Anti epileptic drug polytherapy;Secondary Objective: ;Primary end point(s): The trial will be said to have ended once the last enrolled patient completes the second assessment also known as the follow up assessment for the purpose of this study. | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed