A open-label study of M071754 in patients with infantile spasms
- Conditions
- infantile spasms
- Registration Number
- JPRN-jRCT2080222508
- Lead Sponsor
- Alfresa Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, efficacy, blood taurine<br>Safety:<br>- Ophthalmologic examination, vital sign, height/weight, Laboratory test, ECG, MRI (head), adverse events<br>Efficacy:<br>- Frequency of spasms, disappearance of spasms in the maintenance phase.<br>- Disappearance of hypsarrhythmia
- Secondary Outcome Measures
Name Time Method