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Clinical Trials/CTRI/2013/07/003843
CTRI/2013/07/003843
Completed
Phase 3

Safety, Feasibility And Effectiveness Of Oral Zonisamide Monotherapy In Comparison With Intramuscular Adrenocorticotropic Hormone In Treatment Naïve Infants With West Syndrome: A Preliminary Study

PGIMER0 sites30 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
PGIMER
Enrollment
30
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
PGIMER

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of West syndrome by clinical assessment and EEG

Exclusion Criteria

  • •1\.Suspected or proven cases of tuberous sclerosis
  • •2\.Suspected or proven neurometabolic disease, degenerative brain disease and any progressive neurologic disease other than West syndrome
  • •3\.Previous treatment (within 28 days) with or a known contraindication to ACTH or zonisamide treatment
  • •4\.Inability of parents or guardians to give informed signed consent
  • •5\.Inability of parents or guardians to provide data of outcome as when spasms stop / Inability to come for follow\-up

Outcomes

Primary Outcomes

Not specified

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