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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 accountability

palatability 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

Page last updated: August 23, 2015

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