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Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasms

Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasms

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045702
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-04-21
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

infantile spasms

Interventions

experimental group:Use vitamin B1
control group:Vitamin B1 is not used

Sponsors

Faculty of Pediatrics, the first Medical Centre, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 2 months-2 years; 2. Clinically diagnosed as infantile spasm by an expert in pediatric neurology; 3. Standard, sleep, long-range, or video EEG is interpreted by a neuro-electrophysiological expert, showing diffuse high-amplitude slow rhythm, extensive spikes and slow activity, localized, multifocal spikes and sharp waves of high arrhythmia (or Atypical height arrhythmia); 4. Anti-epileptic drugs were not adjusted within two weeks and the epilepsy condition was stable; 5. Are taking vigabatrin for more than 1 week; 6. There are abnormal changes of vigabatrin-associated brain abnormalities on MRI (defined as T2WI high signal in the thalamus, globus pallidus, brainstem, and cerebellar dentate nucleus, and diffusion imaging (DWI) high signal); 7. All parents or guardians of the enrolled patients signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are other serious diseases that are not suitable for participating in the treatment, such as acute or infectious diseases, such as sepsis, pneumonia, urinary tract infection, electrolyte disorders, etc.; 2. Vitamin B1 is being taken orally; 3. Suffer from metabolic diseases; 4. Are participating in other medical experiments.

Design outcomes

Primary

MeasureTime frame
Scoring of abnormal signal area of vigabatrin-associated brain abnormalities on MRI;Seizure frequency;EEG score;

Countries

China

Contacts

Public ContactZou Liping

Faculty of Pediatrics, the First Medical Centre, Chinese PLA General Hospital

zouliping21@sina.com+86 13911880469

Outcome results

None listed

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