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Pivotal phase III trial of arbaclofen placarbil for the treatment of spasticity in patients with multiple sclerosis. A 13-week double-blind, randomised, placebo-controlled trial followed by an open-label extension.

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Trial Profile

Pivotal phase III trial of arbaclofen placarbil for the treatment of spasticity in patients with multiple sclerosis. A 13-week double-blind, randomised, placebo-controlled trial followed by an open-label extension.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2021

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At a glance

  • Drugs Arbaclofen placarbil (Primary)
  • Indications Multiple sclerosis; Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors XenoPort

    • Most Recent Events

    • 20 May 2013 Status changed from active, no longer recruiting to completed, as reported by a Xenoport media release.
    • 20 May 2013 Co-primary endpoints 'Statistically significant improvements in scores on the Ashworth Scale and the 7-point Patient Global Impression of Change scale' have not been met, as reported by a XenoPort media release.
    • 23 Mar 2013 182 patients (91% of the targeted enrollment) have been enrolled to date.
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