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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|
|Ages||Min: 1 Month Max: 6 Years|
- Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02220114
| Link to official Clinicaltrials.gov listing