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6 results

  • Chapter 35 - Teriflunomide to treat multiple sclerosis

  • from Section III - Clinical trials of multiple sclerosis therapies
  • Edited by Jeffrey A. Cohen, Richard A. Rudick
  • Book:
    Multiple Sclerosis Therapeutics
    Published online:
    05 December 2011
    Print publication:
    20 October 2011, pp 410-417

  • Summary

    Glatiramer acetate (GA) seems to affect immune cells in an antigenic specific way, and could be considered as an example of a therapeutic vaccination, as opposed to the prophylactic vaccinations commonly used for infectious diseases. The first human use of GA was in three patients with acute disseminated encephalomyelitis and four in the terminal stages of multiple sclerosis (MS). Cross-sectional analysis of data from the extended, open label follow-up of the US trial investigated the consequences of long-term GA treatment on several magnetic resonance imaging (MRI) markers of MS activity and disease burden. As GA has unique mechanisms of action, which differs from those of other MS disease therapies, use in combination with other agents might produce additive or synergistic therapeutic effects and better efficacy. The effects of oral GA were extensively studied in both rodents and primates in acute and chronic relapsing experimental autoimmune encephalomyelitis (EAE) models.

  • 62 - Rehabilitation in multiple sclerosis

  • from Section IV - Therapy in clinical practice
  • Edited by Jeffrey A. Cohen, Richard A. Rudick
  • Book:
    Multiple Sclerosis Therapeutics
    Published online:
    05 December 2011
    Print publication:
    20 October 2011, pp 724-730

  • Summary

    The atypical characteristics of primary progressive multiple sclerosis (PPMS) have presented problems in the recruitment to and design of therapeutic trials. The problem areas in the implementation of therapeutic trials are: diagnostic criteria, sample size calculations, and choice of outcome measures. Although there is no definitively proven disease-modifying treatment available for PPMS, several randomized controlled trials have now been specifically designed for this group. The clinical trials in PPMS are based on glatiramer acetate and rituximab. The planned clinical trials in PPMS are based on fingolimod (FTY720) and cladribine. The smaller trials in PPMS are based on Interferon beta-1a, Interferon beta-1b, mitoxantrone and riluzole. A retrospective open-label study of intravenous cyclophosphamide and methylprednisolone in progressive MS included 128 patients with PPMS. PPMS may be the ideal model to investigate disease progression and neuronal protection, and is becoming an important focus for treatment trials in these areas.

  • 36 - High-dose methylprednisolone to treat multiple sclerosis

  • from Section III - Clinical trials of multiple sclerosis therapies
  • Edited by Jeffrey A. Cohen, Richard A. Rudick
  • Book:
    Multiple Sclerosis Therapeutics
    Published online:
    05 December 2011
    Print publication:
    20 October 2011, pp 418-435

  • Summary

    The pharmacokinetics of a single I.V dose of natalizumab were studied in a phase 1, dose-escalation study in 28 multiple sclerosis (MS) patients. As part of the clinical trial program to establish the pharmacokinetic/pharmacodynamic and safety profiles of natalizumab, four Phase 1, dose-finding studies were conducted. An additional Phase 2 study was conducted to evaluate the safety and efficacy of natalizumab in combination with glatiramer acetate (GA). One of the recommendations of the therapeutics and technology assessment subcommittee of the AAN about the use of natalizumab was to carefully monitor patients receiving natalizumab to establish its long-term safety i.e. the true risk of progressive multifocal leukoencephalopathy (PML). Large Phase 3 trials of natalizumab alone or in combination with interferon (IFN)β-1a show that natalizumab reduces the progression of disability, and dramatically reduces the frequency of relapses and magnetic resonance imaging (MRI) lesion formation in patients with relapsing MS.

  • Chapter 19 - Treatment and prognosis of acute disseminated encephalomyelitis

  • from Section 4 - ADEM
  • Edited by Dorothée Chabas, University of California, San Francisco, Emmanuelle L. Waubant, University of California, San Francisco
  • Book:
    Demyelinating Disorders of the Central Nervous System in Childhood
    Published online:
    11 April 2011
    Print publication:
    17 March 2011, pp 212-222

  • Summary

    This chapter presents the literature review on disease-modifying therapies (DMT) for children with multiple sclerosis (MS). Four first-line DMTs have been approved for treatment of relapsing-remitting (RR) MS in the adult population. They include glatiramer acetate, interferon beta (IFNB)-1a IM, IFNB-1a SC, and IFNB-1b SC. Large phase III studies showed that chronic administration of recombinant IFNB reduced the number of relapses and slowed progression of physical disability in adult patients with RR MS. Abnormalities in liver function tests (LFTs) may be pronounced in younger children taking interferon. The glatiramer acetate is designed to mimic human myelin basic protein and is postulated to induce the myelin-specific response of suppressor T-lymphocytes and to inhibit specific effector T-lymphocytes. Breakthrough disease is a concern in the pediatric MS population. Proposed consensus criteria for breakthrough disease in adults include increase in relapse number, new or recurrent MRI lesions, and worsening of cognitive or motor disability.

  • Progress in Neurotherapeutics and Neuropsychopharmacology 2008

  • Jeffrey L. Cummings
  • Journal:
    Progress in Neurotherapeutics and Neuropsychopharmacology / Volume 3 / Issue 1 / January 2008
    Published online by Cambridge University Press:
    16 January 2008, pp. 1-11
    Print publication:
    January 2008

  • ABSTRACT

    There has been continuous progress in neurotherapeutics and neuropsychopharmacology in the past year. Notable are the reports of successful preliminary disease-modifying trials in Niemann-Pick disease and Friedreich's ataxia. Progress also has been made in treatment of migraine, stroke, epilepsy, multiple sclerosis, traumatic brain injury, and pain. Biomarkers are increasingly used to establish proof of pharmacology including measures of cerebrospinal fluid constituents and brain changes on magnetic resonance imaging. There is an increasing diversity of patient populations participating in clinical trials, including pediatric migraine and traumatic brain injury.

  • Optimal Dosing of Immunomodulating Drugs: A Dose-Comparison Study of GA in RRMS

  • Daniel Wynn, Catherine Meyer, Neil Allen, Dennis O'Brien
  • Journal:
    Progress in Neurotherapeutics and Neuropsychopharmacology / Volume 3 / Issue 1 / January 2008
    Published online by Cambridge University Press:
    22 October 2007, pp. 137-151
    Print publication:
    January 2008

  • ABSTRACT

    Background: Though indications of a dose–response for glatiramer acetate (GA) were apparent during early drug development and clinical testing, no formal dose-comparisons of GA had been conducted before the present study. Design/Methods: This multicenter, randomized, double-blind study compared the safety and efficacy of two GA doses: 20 mg/day, the currently approved dose, versus 40 mg/day. Relapsing–remitting multiple sclerosis (RRMS) patients with active disease (1–15 gadolinium-enhancing (GdE) lesions on screening magnetic resonance imaging (MRI) and ≥1 relapse in the previous year) were eligible. The primary outcome was change from baseline in total number of GdE lesions at 7, 8, and 9 months. Other outcomes included effects on relapse, changes in expanded disability status scale (EDSS) scores, and responder analyses. Results: Benefits of the 40 mg GA dose versus the 20 mg dose on GdE lesions were evident by month 3. Additionally, significant advantages of the 40 mg dose were observed for time to first relapse and proportion of relapse-free patients. There was a trend for better outcomes with 40 mg/day GA for the primary efficacy measure, but the difference between doses was not statistically significant. Both GA doses were safe and similarly well tolerated. Interpretation: A 40 mg/day GA dosage may be more effective than the 20 mg/day recommended dosage for reducing disease activity, and appears to have an earlier onset of action. A large, phase III study is underway to confirm these findings.