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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

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Trial Profile

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2024

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Sciatica
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR
  • Sponsors Scilex Holding; Semnur Pharmaceuticals

    • Most Recent Events

    • 14 Jun 2024 Results published in the PAIN Journal
    • 02 Nov 2023 According to a Scilex Holding media release, based on the advisement received from FDA on CLEAR trial, company is planning to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it will seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection.
    • 02 Nov 2023 According to a Scilex Holding media release, today announced a positive Type C meeting with the U.S. Food and Drug Administration (FDA). The Company received an advisement on expectations and requirements to file the NDA, including clinical data. Scilex intends to file the SP-102 NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Dexamethasone sodium phosphate injection.

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