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Status:

COMPLETED

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

Lead Sponsor:

Orphelia Pharma

Collaborating Sponsors:

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

Hospices Civils de Lyon

Conditions:

Infantile Spasms

Eligibility:

All Genders

1-6 years

Phase:

NA

Brief 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 e...

Eligibility Criteria

Inclusion

  • 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 under Sabril® or naive patients.
  • Patients under a twice-a-day posology of Sabril® or patients for whom vigabatrin will be given twice daily.
  • Non inclusion Criteria:
  • 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 \< 1.750 Kgs.
  • Any planned major surgery within the duration of the trial.
  • Participation in any other clinical trial within 3 months prior to V1.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2016

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT02220114

    Start Date

    May 1 2014

    End Date

    December 1 2016

    Last Update

    April 24 2018

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Service de neurologie pédiatrique - CHU

    Amiens, France, 80054

    2

    Service de neurologie pédiatrique - CHU

    Angers, France, 49033²

    3

    Service de neuropédiatrie - CHU Pellegrin Enfants

    Bordeaux, France, 33076

    4

    Service de neurologie infantile - Hôpital Salengro

    Lille, France, 59037