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Effect of levetiracetam and topiramate in infantile spasms

Clinical trial of evaluation of effectiveness and clinical side effects of levetiracetam and topiramate in control of seizures of oral prednisolone refractory infantile spasms

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091027002639N21
Enrollment
60
Registered
2018-09-22
Start date
2018-08-25
Completion date
Unknown
Last updated
2018-10-11

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: Intervention group1: Topiramate tablet of 25 or 50 mg from Darou Pakhsh Co, Iran with dosage of 3- 9mg/kg/day divided into two doses for three months. Intervention 2: Intervention grou

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 1 Years

Inclusion criteria

Inclusion criteria: Age range of 2 months-1 year Having infantile spasms based on definition of the International League Against Epilepsy Resistance of their seizure to treatment of 2 mg/kg/day prednisolone for two months Not used of other antiepileptic drugs

Exclusion criteria

Exclusion criteria: Discontinuation of levetiracetam and topiramate usage for more than one week Allergy to levetiracetam and topiramate Irregular drugs usage Not returning for follow up

Design outcomes

Primary

MeasureTime frame
Daily frequency of seizure. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient parents.;Treatment response. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient parents.

Secondary

MeasureTime frame
Frequency of more than 50 % of reduction in daily frequency of seizure. Timepoint: Before and three months after treatment. Method of measurement: Asking from parents of patient.;Clinical side effects. Timepoint: During three months of treatment. Method of measurement: Asking from parents of patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Nahid Zareeian

Yazd University of Medical Sciences

zpneda@yahoo.com+98 35 3822 4000

Outcome results

None listed

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