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Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy

NCT02220114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-04-24

No results posted yet for this study

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 parameters,
* evaluation of the tolerance,
* measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.

Conditions

  • Infantile Spasms

Interventions

DRUG

Vigabatrin: Vigabatrin new ST formulation then Sabril®

* first "treatment" phase (V1/D1-V3/D84), in which patients already under Sabril® "granules for oral solution" and naive patients start the new ST formulation; patients already under Sabril® will start at the same dose and regimen as their usual Sabril®. Dose and regimen for naive patients will be chosen according to SPC. * second "treatment" phase (V3/D84-V4/D98) in which the patient is switched to Sabril® "granules for oral solution" (supplied by sponsor) for 15 days at the same dose as under the new ST formulation. Dose and treatment regimen should be maintained as in first treatment phase. \- At V4/D98, patients who received Sabril® "granules for oral solution" (supplied by sponsor) continue with marketed Sabril® treatment (or switches to another AED, according to the natural evolution of the patient's condition and upon investigator decision).

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Hospices Civils de Lyon

    collaborator OTHER

  • National Research Agency, France

    collaborator OTHER

  • Orphelia Pharma

    lead INDUSTRY

Principal Investigators

  • Rima NABBOUT · Hôpital Necker Enfants Malades - APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02220114 on ClinicalTrials.gov