Book contents
- Frontmatter
- Contents
- Contributors
- Progress in Neurotherapeutics and Neuropsychopharmacology 2008
- Triflusal versus Aspirin for the Prevention of Stroke
- The Argatroban and tPA Stroke Study
- Use of Selegiline as Monotherapy and in Combination with Levodopa in the Management of Parkinson's Disease: Perspectives from the MONOCOMB Study
- Ropinirole 24-h Prolonged Release in Advanced Parkinson Disease: Review of a Randomized, Double-Blind, Placebo-Controlled Study (EASE PD-Adjunct Study)
- Insulin Resistance Alzheimer's Disease: Pathophysiology and Treatment
- Targeting Amyloid with Tramiprosate in Patients with Mild-to-Moderate Alzheimer Disease
- Intranasal Zolmitriptan Is Effective and Well Tolerated in Acute Cluster Headache: A Randomized Placebo-Controlled Double-Blind Crossover Study
- Optimal Dosing of Immunomodulating Drugs: A Dose-Comparison Study of GA in RRMS
- Tetrathiomolybdate versus Trientine in the Initial Treatment of Neurologic Wilson's Disease
- Randomized Clinical Trials of Pregabalin for Neuropathic Pain: Methods, Results, and Implications
- Effect of Methylphenidate in Patients with Acute Traumatic Brain Injury; a Randomized Clinical Trial
- Improvement in Speeded Cognitive Processing After Anti-epileptic Drug Withdrawal–A Controlled Study in Mono-therapy Patients
- A Randomized-Controlled Trial of Bilateral rTMS for Treatment-Resistant Depression
- Serotonin Related Genes Affect Antidepressant Treatment in Obsessive–Compulsive Disorder
- Night Eating Syndrome and Results from the First Placebo-Controlled Trial of Treatment, with the SSRI Medication, Sertraline: Implications for Clinical Practice
- Modafinil: A Candidate for Pharmacotherapy of Negative Symptoms in Schizophrenia
- New Approaches to Treatment of Schizophrenia by Enhancing N-methyl-D-aspartate Neurotransmission
- Subject Index
- Author Index
Optimal Dosing of Immunomodulating Drugs: A Dose-Comparison Study of GA in RRMS
Published online by Cambridge University Press: 13 May 2010
- Frontmatter
- Contents
- Contributors
- Progress in Neurotherapeutics and Neuropsychopharmacology 2008
- Triflusal versus Aspirin for the Prevention of Stroke
- The Argatroban and tPA Stroke Study
- Use of Selegiline as Monotherapy and in Combination with Levodopa in the Management of Parkinson's Disease: Perspectives from the MONOCOMB Study
- Ropinirole 24-h Prolonged Release in Advanced Parkinson Disease: Review of a Randomized, Double-Blind, Placebo-Controlled Study (EASE PD-Adjunct Study)
- Insulin Resistance Alzheimer's Disease: Pathophysiology and Treatment
- Targeting Amyloid with Tramiprosate in Patients with Mild-to-Moderate Alzheimer Disease
- Intranasal Zolmitriptan Is Effective and Well Tolerated in Acute Cluster Headache: A Randomized Placebo-Controlled Double-Blind Crossover Study
- Optimal Dosing of Immunomodulating Drugs: A Dose-Comparison Study of GA in RRMS
- Tetrathiomolybdate versus Trientine in the Initial Treatment of Neurologic Wilson's Disease
- Randomized Clinical Trials of Pregabalin for Neuropathic Pain: Methods, Results, and Implications
- Effect of Methylphenidate in Patients with Acute Traumatic Brain Injury; a Randomized Clinical Trial
- Improvement in Speeded Cognitive Processing After Anti-epileptic Drug Withdrawal–A Controlled Study in Mono-therapy Patients
- A Randomized-Controlled Trial of Bilateral rTMS for Treatment-Resistant Depression
- Serotonin Related Genes Affect Antidepressant Treatment in Obsessive–Compulsive Disorder
- Night Eating Syndrome and Results from the First Placebo-Controlled Trial of Treatment, with the SSRI Medication, Sertraline: Implications for Clinical Practice
- Modafinil: A Candidate for Pharmacotherapy of Negative Symptoms in Schizophrenia
- New Approaches to Treatment of Schizophrenia by Enhancing N-methyl-D-aspartate Neurotransmission
- Subject Index
- Author Index
Summary
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 relapsefree 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.
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- Progress in Neurotherapeutics and Neuropsychopharmacology , pp. 137 - 152Publisher: Cambridge University PressPrint publication year: 2008
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