Trial intelligence / Profile preview

Zaurategrast in Relapsing MS

NCT00484536Phase 2

Key facts

Status
Terminated
Start
May 2007
Primary completion
Nov 2009
Countries
11
Sponsor
UCB
Modality
Prodrugs/Conditional Activator Small Molecules
Conditions
multiple sclerosis (MS)
01

Overview

Phase 2, randomised, double-blind trial of zaurategrast in multiple sclerosis (MS) (3 arms), sponsored by UCB. Primary endpoint: Cumulative number of newly active lesions on standardized brain MRI scans at 28 weeks. Started May 2007; status: terminated.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • CDP323 1000 mg/day

    CDP323 500 mg bid

  • CDP323 500 mg/day

    CDP323 500 mg once daily

  • Placebo

    Placebo capsules once daily

03

Who it enrols

Patients with relapsing forms of MS, EDSS 0-5.5, active disease on MRI, and failed prior treatment with beta-interferons or glatiramer acetate.

04

Endpoints

Primary

  • Cumulative number of newly active lesions on standardized brain MRI scans

Secondary

  • Occurrence of any treatment emergent adverse event

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