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

Orphelia Pharma

Status: Completed

Conditions: Infantile Spasms

Treatments: Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02220114

TGO-VGB-III-01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Vigabatrin: Vigabatrin new ST formulation then Sabril®

Other group

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.

Treatment:

Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril®