EFFICACY AND SAFETY OF TWO FIXED DOSES (160 OR 320 MG/DAY) OF RALFINAMIDE IN PATIENTS WITH CHRONIC NEUROPATHIC LOW BACK PAIN. A MULTICENTER, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED 12-WEEK STUDY WITH LONG-TERM EXTENSION.

Trial Profile

EFFICACY AND SAFETY OF TWO FIXED DOSES (160 OR 320 MG/DAY) OF RALFINAMIDE IN PATIENTS WITH CHRONIC NEUROPATHIC LOW BACK PAIN. A MULTICENTER, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED 12-WEEK STUDY WITH LONG-TERM EXTENSION.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Sep 2017

At a glance

  • Drugs Ralfinamide (Primary)
  • Indications Back pain; Neuropathic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms SERENA
  • Sponsors Newron Sweden AB
  • Most Recent Events

    • 14 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 19 Oct 2012 Planned number of patients changed from 400 to 560.
    • 19 Oct 2012 Planned number of patients changed from 400 to 560.
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