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An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)

Trial Profile

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2022

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At a glance

  • Drugs Arbaclofen (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms OS440-3005
  • Sponsors RVL Pharmaceuticals

Most Recent Events

  • 21 Apr 2022 Status changed from active, no longer recruiting to completed.
  • 30 Mar 2021 According to an Osmotica Pharmaceutical media release, the company had constructive Type A meeting with the FDA and the company is exploring a number of options define a path forward, which will most likely include another clinical trial.
  • 29 Dec 2020 According to an Osmotica Pharmaceutical media release, the company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.

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