CompletedNot a drug-phase studyRelapsing MSNCT00039988

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

  • Albuterol placebo

What it measured

Main measures

  • Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC)

    Throughout study

    Disability progression
  • Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines

    At Months 3, 6, and 12

    Immune response

Other measures (6)

  • Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate

    Throughout study

    Immune response
  • Change in percentage of IL-12-producing monocytes by intracytoplasmic staining

    Throughout study

    Immune response
  • Time to first exacerbation

    Throughout study

  • Number and severity of exacerbations

    Throughout study

  • MRI evidence as measured by T2 lesion volume, number of enhancing lesions on T1 weighted images, and measurements of atrophy (brain parenchymal fraction, atrophy index)

    At study entry and Months 12 and 24

    MRI lesionsBrain volume loss
  • Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores

    Throughout study

    Disability progression

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria Patients may be eligible for this study if they: * Have been diagnosed with RR-MS, within 2 years of diagnosis. * Are 18-55 years old. * Have RR-MS with evidence of demyelination on MRI scanning of the brain. * Have extended disability status scale (EDSS) scores between 0 and 3.5. * Have not taken Copaxone or oral myelin. * Have not had immunomodulating therapy for the past 3 months. * Have not taken immunosuppressants. * Have not had steroid treatment 1 month before entry. * Have no evidence of active infection or cancer. Exclusion Criteria Patients may not be eligible for this study if they: * Have a normal brain MRI. * Are not willing to practice contraception (applies to women who are able to have children). * Are pregnant or breast-feeding. * Are currently taking any of the following drugs: beta2-adrenergic agonist or antagonist, diuretics, tricyclic antidepressants, or monoamine oxidase inhibitors. * Have heart, blood, liver, or kidney problems. * Have a disease that affects blood clotting or lung function. * Have abnormalities that relate to the endocrine system. * Have a history of alcohol or drug abuse within 6 months of enrollment. * Have been diagnosed with primary progressive MS, in which the disease slowly worsens without periods of recovery.

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

About this trial

In the sponsor's words

The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.

Papers

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Related trials

History

    1. Started

      Nov 2001

    2. Main results due

      Mar 2006

    3. Finished

      Nov 2007

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