Clinical Trial Details
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NCT02220114 : Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
AgesMin: 1 Month Max: 6 Years
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.
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