Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

    • 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.
    • 27 Oct 2023 According to a Scilex Holding media release, the company participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement path forward to file an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica) from the FDA.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top