A open-label study of M071754 in patients with infantile spasms.

Phase 1

• Conditions: Patients diagnosed with infantile spasms; MedDRA version: 20.0Level: PTClassification code 10021750Term: Infantile spasmsSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000611-17-Outside-EU/EEA
• Lead Sponsor: Alfresa Pharma Corporation and Sanofi KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-28
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 17

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 17
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified