Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
Information source: Targeon SAS
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infantile Spasms
Intervention: Vigabatrin: Sabril® then Vigabatrin new ST formulation. (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Targeon SAS Official(s) and/or principal investigator(s): Rima NABBOUT, Principal Investigator, Affiliation: Hôpital Necker Enfants Malades - APHP
Overall contact: Hugues BIENAYME, Phone: +33142770818, Email: h.bienayme@targeon-pharma.com
Summary
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the
dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin
(Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6
years) and 500 mg granules for oral solution sachets (for infants and children below 6
years). Sabril™ is not adapted for administration to infants when a fraction of the sachet
is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often
required.
This study is a descriptive, non-randomized, open label multi-centric acceptability study in
infants and children affected with infantile spasms. The primary objective is to describe
the adherence to the new formulation. Secondary objectives include:
- evaluation of the palatability and user-friendliness of the new treatment,
- evaluation of the pharmacokinetic parameters of the new formulation,
- PK study,
- evaluation of the tolerance,
- measurement of taurine plasma levels. This study will recruit 50 patients with
infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 12
clinical sites in France.
Clinical Details
Official title: Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adherence to the new Soluble Tablets (ST) formulation of Vigabatrin (VGB) using Medication Event Monitoring System (MEMS)
Secondary outcome: Adherence to the new ST formulation and to Sabril® granules for oral solution, by treatment unit accountabilitypalatability of the new ST formulation and of Sabril® "granules for oral solution". Ease of use of the new ST formulation and of Sabril® "granules for oral solution". Safety and tolerance pharmacokinetic parameters for the new ST formulation (population PK). Pharmacokinetic parameters for the new ST formulation (population PK) : Area under the curve (AUC), Tmax, Cmax, T½, Ka, V/F, Cl/F Evaluation of the taurine plasma levels in children treated by vigabatrin. Taurine plasma concentration will be measured and a relationship between vigabatrin exposition and taurine plasma levels will be sought.
Eligibility
Minimum age: 1 Month.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset
seizures (POS).
- Infants > 1 month and < 6 months; infants > 6 months and < 2 years; and children > 2
years and < 6 years.
- Patients stabilized under Sabril® for at least 2 weeks prior to V1: patients with no
spasms/POS or with a stable frequency of spasms/POS (i. e. with no more than 50%
variation in the number of spasms/POS) within 2 weeks prior to V1.
- Patients under a twice-a-day posology of Sabril®.
Non inclusion 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.
Locations and Contacts
Hugues BIENAYME, Phone: +33142770818, Email: h.bienayme@targeon-pharma.com
Service de neurologie pédiatrique - CHU, Amiens 80054, France; Recruiting Patrick BERQUIN, Principal Investigator
Service de neurologie pédiatrique - CHU, Angers 49033², France; Recruiting Sylvie N'GUYEN, Principal Investigator
Service de neuropédiatrie - CHU Pellegrin Enfants, Bordeaux 33076, France; Completed
Service de neurologie infantile - Hôpital Salengro, Lille 59037, France; Not yet recruiting Louis VALLEE, Principal Investigator
Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant, Lyon 69677, France; Recruiting Dorothée VILLE, Principal Investigator
Service de neurologie pédiatrique - Hôpital de la Timone, Marseille 13385, France; Recruiting Nathalie VILLENEUVE, Principal Investigator
Service de neurologie pédiatrique - Hôpital Necker Enfants Malades, Paris 75015, France; Active, not recruiting
Service de neuropédiatrie - Hôpital Robert Debré, Paris 75019, France; Not yet recruiting Stephane AUVIN, Principal Investigator
Service de neurologie pédiatrique - Hôpital Sud, Rennes 35203, France; Recruiting Sylvia NAPURI, Principal Investigator
Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre, Strasbourg 67098, France; Recruiting Anne DE SAINT MARTIN, Principal Investigator
Service de neuropédiatrie - Hôpital Purpan, Toulouse 331059, France; Recruiting Claude CANCES, Principal Investigator
Service de neuropédiatrie - Hôpital de Clocheville, Tours 37044, France; Recruiting Marie-Anne BARTHEZ, Principal Investigator
Additional Information
Starting date: May 2014
Last updated: August 18, 2014
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