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

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Brief Title

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

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

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 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.
    



Study Type

Interventional


Primary Outcome

Individual 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

Condition

Infantile Spasms

Intervention

Vigabatrin: Vigabatrin new ST formulation then Sabril®

Study Arms / Comparison Groups

 Vigabatrin: Vigabatrin new ST formulation then Sabril®
Description:  Sabril®: sachet for oral solution 500 mg, 50 to 100mg/Kg/day, twice a day, 14 days.
Vigabatrin new ST formulation: Soluble tablets 100 or 500 mg, 50 to 100mg/Kg/day, twice a day, 12 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

38

Start Date

May 2014

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility 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 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.
      

Gender

All

Ages

1 Month - 6 Years

Accepts Healthy Volunteers

No

Contacts

Rima NABBOUT, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02220114

Organization ID

TGO-VGB-III-01


Responsible Party

Sponsor

Study Sponsor

Orphelia Pharma

Collaborators

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

Study Sponsor

Rima NABBOUT, Principal Investigator, Hôpital Necker Enfants Malades - APHP


Verification Date

April 2018