Skip to content

Comparison of efficacy of Topiramate and Nitrazepam in infantile spasms treatment

Comparison of efficacy of Topiramate and Nitrazepam in infantile spasms treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138808052639N1
Enrollment
50
Registered
2009-12-12
Start date
2008-09-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Infantile spasms. Other generalized epilepsy and epileptic syndromes

Interventions

Intervention 1: Topiramate, oral, 3-12 mg/kg/day for two months. Intervention 2: Nitrazepam, oral, 0.5-1 mg/kg/day for two months.
Treatment - Drugs
Topiramate, oral, 3-12 mg/kg/day for two months
Nitrazepam, oral, 0.5-1 mg/kg/day for two months

Sponsors

Shaheed Sadoughi University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Age range : 2 months to 2 years, presence of infantile spasms , Exclusion criteria : Low compliance, hard to follow up, recieving anticonvulsant drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Monthly freuency of seizures. Timepoint: Two months before intervention, one and two months after intervention. Method of measurement: Recording seizure attacks by parents.

Secondary

MeasureTime frame
Side effects. Timepoint: Every month during the study period. Method of measurement: Recording seizure attacks by parents.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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