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Related Experiment Videos

Clinical trials in multiple sclerosis: methodological issues.

Giancarlo Comi1, Massimo Filippi

  • 1Department of Neurology and Clinical Neurophysiology, Milan, Italy. g.comi@hsr.it

Current Opinion in Neurology
|May 14, 2005
PubMed
Summary
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Designing clinical trials for relapsing multiple sclerosis (MS) presents challenges. Active comparators are preferred over placebo arms, and advanced MRI techniques show promise for tracking neurodegeneration.

Area of Science:

  • Neurology
  • Clinical Trial Design
  • Immunosuppressive Therapy

Background:

  • Partially effective treatments for relapsing multiple sclerosis (MS) create ethical and practical issues for clinical trial design.
  • Patient reluctance to participate in placebo-controlled trials is increasing.

Purpose of the Study:

  • To discuss alternative clinical trial designs for relapsing MS.
  • To review accepted and emerging outcome measures for disease activity and progression.
  • To highlight the potential of advanced MRI techniques.

Main Methods:

  • Review of current recommendations for clinical trial design.
  • Evaluation of accepted surrogate markers for disease activity (relapses, active lesions, MRI lesions).
  • Exploration of novel clinical scales for impairment, disability, and quality of life.

Related Experiment Videos

  • Assessment of modern quantitative MRI techniques for irreversible tissue loss.

    • Main Results:

    • Active comparator trials are becoming an attractive option for testing new MS drugs.
    • Current clinical markers for irreversible tissue damage in MS lack reliability and sensitivity.
    • Advanced MRI techniques show promise for monitoring neurodegenerative aspects of MS.

    Conclusions:

    • Clinical trial designs for relapsing MS need to adapt to ethical and practical considerations.
    • There is a need for reliable markers of MS progression.
    • Quantitative MRI offers a promising avenue for assessing neurodegeneration in MS.