CompletedPhase 2Relapsing MSNCT003491932004-003943-28

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

Placebo or sham

  • Placebo

What it measured

Main measures

  • Reduction of brain lesions in the last 4 months of the study

    36 weeks

    MRI lesions
  • The cumulative number of enhancing lesions on T1-weighted images taken on weeks 12, 16, 20, 24, 28, 32 and 36 (primary end point).

    MRI lesions

Other measures (1)

  • Relapse rate

    36 weeks

    Relapses

Who could take part

Relapsing MS · 18 to 50

Inclusion Criteria: 1. Willing and able to give written informed consent 2. Confirmed MS diagnosis as defined by the McDonald criteria 3. R-R MS disease course. 4. At least one gadolinium-enhanced lesion on screening MRI 5. Women of child-bearing potential must practice a reliable method of birth control. 6. Must understand the requirements of the study and agree to comply with the study protocol. Exclusion Criteria: 1. Subjects who suffer from any form of progressive MS. 2. Any condition which the investigator feels may interfere with participation in the study. 3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, 4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening 5. Previous treatment with immunomodulators within two months prior to screening

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

About this trial

In the sponsor's words

Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions. The duration of the current study is 36 weeks.

Papers

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Linked trials

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

Related trials

History

    1. Started

      Mar 2005

    2. Main results due

      Jun 2006

    3. Finished

      Aug 2006

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