CompletedPhase 2MS (type not specified)2005-005592-14

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Epoetin alfa

    Erythropoietin receptor agonist

  • Methylprednisolone

    Glucocorticoid receptor agonist

What it measured

Main measures

  • The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline.

    Retina scans (OCT)

Who could take part

MS (type not specified)

Inclusion: To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization: Exclusion: Candidates will be excluded from study if any of the following exclusion criteria exist at the time of randomization:

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

About this trial

In the sponsor's words

The safety and tolerability of Epo in combination with Mpred in subjects with optic neuritis/MS is a primary interest of this study. Additionally, an objective of primary interest is to calculate an estimate for the efficacy of this therapy with respect to nerve fiber loss in the optical nerve head after an episode of acute optic neuritis. Nerve fiber loss will be measured by OCT using the change in retinal nerve fiber layer thickness around the optical nerve head and the change of neural tissue volume in the optical nerve head itself. The measurements will be performed at baseline, week 4, week 8, and week 16. The measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.

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History

    1. Started

      May 2006

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