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Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 25, 2021 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 2023 to Jun 2026
    • Study completion date: Dec 2023 to Dec 2026
    v4
  2. Start date changed from estimate of May 2020 to May 18, 2020v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Enrollment target: 182 to 250
    • Study sites: 0 to 1
    • Start date: Apr 2020 to May 2020
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 5 to 7
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.
Trial Details
NCT Number NCT04302116
Lead Sponsor Kullasate Sakpichaisakul
Conditions
(from sponsor)		 Infantile Spasm, West Syndrome
Related terms Spasms, Infantile
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov