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Comparing two Medications in Steroid and Vigabatrin Resistant West Syndrome: Clonazepam versus Nitrazepam

A Randomized Control Trial on effectiveness of Clonazepam Versus Nitrazepam after failure of Steroids and Vigabatrin in Infantile Epileptic Spasm Syndrome. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072081
Enrollment
78
Registered
2024-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention1: NITRAZEPAM OR CLONAZEPAM: NITRAZEPAM OR CLONAZEPAM Intervention2: NITRAZEPAM: Drug therapy with Nitrazepam Dose: 0.5-3mg/kg/day Duration:14 days initially and then assess if responded t

Sponsors

INDIRA GANDHI INSTITUE OF CHILD HEALTH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children diagnosed with west syndrome not responding to steroids and Vigabatrin.

Exclusion criteria

Exclusion criteria: Children in whom Benzodiazepines are contraindicated. Children inncompletely treated or partially treated with First Line Drugs

Design outcomes

Primary

MeasureTime frame
To asses the Response in participants in term of reduction in number of spasmsTimepoint: To asses the Response in participants in term of reduction in number of spasms after 2 weeks of Starting the Drug Therapy then follow up after 1motn,3month and 6month.—

Secondary

MeasureTime frame
Developmental improvement in all the developmental milestones.Timepoint: At the end of 6 months of study—

Countries

India

Contacts

Public ContactDr Vidya

INDIRA GANDHI INSTITUE OF CHILD HEALTH ,

drknvraju08@gmail.com9535212556

Outcome results

None listed

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