A single-blind study of M071754 in patients with infantile spasms
Phase 3
- Conditions
- infantile spasms
- Registration Number
- JPRN-jRCT2080222507
- Lead Sponsor
- Alfresa Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Patients diagnosed with infantile spasms manifested by spasms and hypsarrhythmia on electroencephalography
Exclusion Criteria
- 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 previously or currently treated with vigabatrin.
- 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 Efficacy (frequency of spasms at primary evaluation date)<br>Change in frenqyuency spasms form baseline
- Secondary Outcome Measures
Name Time Method Efficacy, safety, pharmacokinetics, blood taurine<br>Efficacy:<br>- Frequency of spasms, disappearance of spasms in the maintenance phase.<br>- Disappearance of hypsarrhythmia<br>Safety:<br>- Ophthalmologic examination, vital sign, height/weight, Laboratory test, ECG, MRI (head), adverse events.