Epilepsy
Conditions
Interventions
Trade Name: Clobazam (Frisium)
Product Name: clobazam
Product Code: PL 13402/0030
Pharmaceutical Form: Tablet
INN or Proposed INN: cloba
Sponsors
liverpool university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Continued seizures despite current treatment with between 1 and 3 conventional antiepileptic drugs (carbamazepine, valproate, lamotrigine, phenytoin, topiramate, levetiracetam, gabapentin). Patients who may have been treated previously with AEDs not in this list will also be included. 2. Patients have been on their existing combination of AEDs for at least 3 months. 3. Addition of clobazam to existing AED regime or switch of one of current AEDs for clobazam is clinically indicated. 4. Any epilepsy syndrome (generalized, localization-related, unclassified). Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Significant learning disability 2. Patient and/or relatives unable to maintain a seizure diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle research objective is to define the genetic and enviromental factors that can predict response to clobazam.;Secondary Objective: ; Primary end point(s): 1. Time to withdrawal of clobazam. a. For any reason b. Due to side effects c. Due to inadequate seizure control d. Combination of b and c 2. Seizure control. a. Seizure frequency per month at 3, 6, 9, and 12 months. b. Number of seizure free days per month at 3, 6, 9 and 12 months. 3. Adverse effects | — |
Countries
United Kingdom
Outcome results
None listed