infantile spasms
Conditions
Sponsors
Alfresa Pharma Corporation
Sanofi KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with infantile spasms and who meet one of the following criteria - Patients who have completed the maintenance phase of the preceding phase III clinical study and have been confirmed efficacy and there is no safety concern - Patients who is taking Vigabatrin (in which case the frequency of spasms before the start of Vigabatrin and the cumulative dose of Vigabatrin must be confirmed) - Patients who has experience to take Vigabatrin (in which case the frequency of spasms before the start of Vigabatrin and the cumulative dose of Vigabatrin must be confirmed) - Patients who has no experience to take Vigabatrin.
Exclusion criteria
Exclusion criteria: - Patients who is taking Vigabatrin more than maximum dose (150mg/kg/day or 3g/day) - Patients with concurrent severe liver/renal disease, cardiac disease, serious gastrointestinal disorder. - Patients who received adrenocorticotropic hormone (ACTH) products or steroids within 4 weeks (28 days) prior to the formal registration of this study. - Patients who have concurrent or a history of ophthalmological complication in whom possible aggravation of the symptoms with vigabatrin. - Patients with concomitant Lennox-Gastaut syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, efficacy, blood taurine Safety: - Ophthalmologic examination, vital sign, height/weight, Laboratory test, ECG, MRI (head), adverse events Efficacy: - Frequency of spasms, disappearance of spasms in the maintenance phase. - Disappearance of hypsarrhythmia | — |
Outcome results
None listed