Phase 3 study of K-828-SP

Phase 3 study of K-828-SP (Long-term study of sodium valproate in child patients with spinal muscular atrophy)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223395

Enrollment

Registered

2016-11-28

Start date

2016-12-12

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

spinal muscular atrophy

Interventions

investigational material(s) Generic name etc : granular powder of SMART INN of investigational material : - Therapeutic category code : 1-- Agents affecting nervous system and sensory organs Dosage an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with SMN 1 gene mutation proven by gene testing (2) Patients of SMA types 1, 2 and 3 (3) Patients under age 15 when agreement was obtained etc

Exclusion criteria

Exclusion criteria: 1) Patients who have had an operation for spine scoliosis 2) Patient with severe liver dysfunction, renal dysfunction 3) Patients with urea cycle abnormalities etc

Design outcomes

Primary

Measure	Time frame
safety efficacy Efficacy: HFMSE Safety: AE and ADR Efficacy: change from baseline Safety: incidence rate	—

Secondary

Measure	Time frame
safety efficacy Efficacy: HFME etc. Safety: vital signs and laboratory tests Efficacy: change from baseline Safety: change from baseline	—

Countries

Japan

Outcome results

None listed

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