A single-blind study of M071754 in patients with infantile spasms

A Phase III study of M071754 - A single-blind study in patients with infantile spasms -

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222507

Enrollment

Registered

2014-06-02

Start date

2014-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infantile spasms

Interventions

investigational material(s) Generic name etc : M071754 INN of investigational material : vigabatrin Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with infantile spasms manifested by spasms and hypsarrhythmia on electroencephalography

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Efficacy (frequency of spasms at primary evaluation date) Change in frenqyuency spasms form baseline	—

Secondary

Measure	Time frame
Efficacy, safety, pharmacokinetics, blood taurine Efficacy: - Frequency of spasms, disappearance of spasms in the maintenance phase. - Disappearance of hypsarrhythmia Safety: - Ophthalmologic examination, vital sign, height/weight, Laboratory test, ECG, MRI (head), adverse events.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026