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Phase 3, Multi-Center, Double-Blind, Randomized, 2-Arm, Parallel Study to Assess the Efficacy and Safety of Ryanodex (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

Trial Profile

Phase 3, Multi-Center, Double-Blind, Randomized, 2-Arm, Parallel Study to Assess the Efficacy and Safety of Ryanodex (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Dantrolene (Primary)
  • Indications Heat stroke
  • Focus Registrational; Therapeutic Use
  • Sponsors Eagle Pharmaceuticals
  • Most Recent Events

    • 12 Nov 2019 According to an Eagle Pharmaceuticals media release, the company enrolled 10 additional patients in this trial at the 2019 Hajj pilgrimage held from 9th-14th Aug in Saudi Arabia, bringing the total number of patients recruited in 2015, 2018 and 2019 to 41.The company has submitted a plan to FDA that proposes reviewing the data collectively for all 41 patients. If FDA agrees with this plan, the company plans to resubmit the New Drug Application of RYANODEX for exertional heat stroke (EHS).
    • 08 Aug 2019 Status has been changed to recruiting.
    • 23 Jul 2019 Planned End Date changed from 1 Sep 2018 to 1 Aug 2019.
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