CompletedPhase 2Relapsing MSNCT010817822009-014339-19

What it found

No result found

We found no results in the registry or in papers.

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • ONO-4641

Placebo or sham

  • ONO-4641 placebo

What it measured

Main measures

  • Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.

    26 weeks

    MRI lesions
  • The primary endpoint will be the cumulative number of T1 weighted gadolinium (Gd)-enhanced lesions obtained with MRI at Weeks 10, 14, 18, 22 and 26. Patients who complete the treatment period or who discontinued during the treatment period and do not proceed to the extension study will enter the 4-week Follow-up Period.

    MRI lesions

Other measures (1)

  • Total volume of Gd-enhanced lesions

    26 weeks

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Adult male or female aged 18-55 years inclusive at screening * Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis Exclusion Criteria: * Multiple Sclerosis course other than relapsing-remitting multiple sclerosis * History of malignancy * History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis) * Inability to undergo Gd-enhanced MRI scans * Diagnosis of diabetes mellitus (type I or type II)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.

Papers

    Loading reviews and guidelines…

    Linked trials

    • Extended by

      DreaMS

      Phase 2 · Stopped early

    Links found where a registry record names another trial's registry number.

    History

      1. Started

        Mar 2010

      2. Main results due

        Dec 2011

      3. Finished

        Dec 2011

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