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Efficacy of low-dose ACTH in the treatment of infantile spasms and changes in inflammatory indexes

Efficacy of low-dose ACTH in the treatment of infantile spasms and changes in inflammatory indexes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053371
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-11-15
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

infantile spasms

Interventions

Experimental group1:After the end of the ACTH treatment for the first 2 weeks, change to oral prednisone 2 mg/kg.d for 2 weeks
Experimental group2:The ACTH dose was increased to 3 IU/kg.d and continued for 2 weeks

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 5 Years

Inclusion criteria

Inclusion criteria: 1. It is more common in infancy; 2. Typical characteristic clinical manifestations: nodding and hugging spasm, peak EEG arrhythmia with mental and motor development retardation; 3. The selected subjects are all new cases and have not been treated with immune preparations or various antiepileptic drugs.

Exclusion criteria

Exclusion criteria: 1. There is a known genetic disease; 2. There are major organ diseases, such as tachyarrhythmia, heart/lung/liver/kidney and other organ damage; 3. The guardian's lack of cooperation, including failure to cooperate with the follow-up.

Design outcomes

Primary

MeasureTime frame
EEG changes before and after medication ;Spastic seizure remission rate and recurrence rate ;Lymphocyte subsets;

Countries

China

Contacts

Public ContactLi Dongfang

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

ldf201310@163.com+86 13808899970

Outcome results

None listed

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