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Assessment of treatment response rate to vigabatrin and prednisolone add-on therapy in patients with infantile spasms

Assessment of treatment response rate to vigabatrin and prednisolone add-on therapy in patients with infantile spasms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002971
Enrollment
50
Registered
2018-07-03
Start date
2017-05-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : When patients were initially diagnosed with West syndrome, they were first given with vigabatrin. Vigabatrin was first tried with 50 mg/kg/day for 1 day, and was escalated to 100 mg/kg/day. Aft

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who were diagnosed with infantile spasms (West syndrome) – who both showed clinical spasms and hypsarrhythmia on EEG.

Exclusion criteria

Exclusion criteria: diagnosis of tuberous sclerosis. on other antiepileptic medications. if their parents or guardians refused to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Cessation of clinical spasms and improvement of EEG (achievement of EEG BASED score of = 2)

Secondary

MeasureTime frame
Adverse reactions of vigabatrin and prednisolone

Countries

Korea, Republic of

Contacts

Public ContactAra Ko

Yonsei University Health System, Severance Hospital

chereara@gmail.com+82-2-2227-4174

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026