Infantile spasms and pharmaco-resistant partial epilepsy MedDRA version: 18.0 Level: PT Classification code 10021750 Term: Infantile spasms System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: vigabatrin
Product Code: VGB-ST
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: VIGABATRIN
CAS Number: 60643-86-9
Current Sponsor code: VGB-ST
Other descriptive name: VGB-ST sol
Sponsors
TARGEON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Boys and girls. - Patients with diagnosed infantile spasms (IS) or pharmaco-resistant partial onset seizures (POS). - Infants > 1 month and 6 months and 2 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Change in anti-epileptic treatment and/or Sabril® dose within 7 days before V1. - Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs. - Subjects receiving vigabatrin through a gastric tube. - Weight < 4 Kgs. - Any planned major surgery within the duration of the trial. - Participation in any other clinical trial within 3 months prior to V1. - Lack of ability or willingness to give informed consent. - Anticipated non-availability for study visits / procedures. - Lack of willingness or inability to co-operate adequately.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the adherence to a new vigabatrin formulation (soluble tablets).;Secondary Objective: 1)Evaluate the palatability and the ease of use of the new vigabatrin formulation. 2)Describe the adherence to Sabril and the new formulation (by treatments accountability) 3)Evaluate the pharmacokinetic parameters of the new vigabatrin formulation. 4)Evaluate the treatment safety, including the visual safety (by electroretinogram). 5)Evaluate the taurine plasma concentrations in children treated with vigabatrin. ;Primary end point(s): The primary endpoint is the proportion of adherent patients for the new VGB formulation. Adherence will be assessed by measurement of the dosing history of patients using an electronic Medication Event Monitoring System (MEMS).;Timepoint(s) of evaluation of this end point: Continuous endpoint between D15 and D98, 12 weeks under VGB-ST. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adherence by accountability of Treatment units for the new ST formulation (number of tablets) and to Sabril® “granules for oral solution” (number of sachets). - Palatability evaluated using a two face visual hedonic scale filled in by the parents and/or by the child, if feasible, on a daily basis. Each “face” of the scale will be assigned a score (1 to 2), and the average score will be calculated for the group. Palatability will be considered good if the average score for the group is at least 1.5 out of a maximum of 2. - Ease of use will be evaluated for Sabril® « granules for oral solution » and for the new ST formulation using two diaries filled by the parents or care-givers during 7 consecutive days. Time required for preparation of both VGB ST and Sabril® administrations will be averaged and compared, together with the global use satisfaction . - Safety measures include: o Results of electroretinogram (when available). o General safety, including: • blood cells count, blood electrolytes, blood ionogram, serum creatinine, liver function assessment • vital signs (cardiac frequency and blood pressure) • adverse events and serious adverse events. - Pharmacokinetic parameters for the new ST formulation (population PK) : AUC, T max, Cmax, T½, Ka, V/F, Cl/F . - Taurine plasma concentration.;Timepoint(s) of evaluation of this end point: - Accountability : D1 to D14 under Sabril ; D15 to D98 under VGB-ST. - Palatability and ease of use, 7 consecutive days :D8 to D14 for Sabril® ; D22 to D28 under VGB-ST. - Safety measures : • blood assessment at V1 and V4, • vital signs at V1, V2, V4 and V5. • AE and SAE at each study visit. - Pharmacokinetic: • After V3, the same day, 1 sample just before treatment and 1 sample 1h after treatment. • At least 1 week before V4, the same day, 1 sample 3 to 5h after treatment and 1 sample 6 to 9 h after treatment. • At V4, 1 sample just before trea | — |
Countries
France
Contacts
Public ContactBehrouz KASSAI KOUPAI
Centre d'Investigation Clinique, HCL Lyon
Outcome results
None listed