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Treatment of Multiple Sclerosis With Copaxone and Albuterol

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmune Centers of Excellence
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00039988
  Purpose

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.


Condition Intervention
Autoimmune Diseases
Multiple Sclerosis
Drug: Glatiramer acetate
Drug: Albuterol

MedlinePlus related topics:   Autoimmune Diseases    Multiple Sclerosis   

ChemIDplus related topics:   Albuterol sulfate    Albuterol    Levalbuterol hydrochloride    Levalbuterol tartrate    Copolymer 1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Efficacy Study
Official Title:   Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and Albuterol

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC)
  • glatiramer acetate-specific cytokine secretion at Months 3, 6 and 12, compared to baseline measurement of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines

Secondary Outcome Measures:
  • Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate
  • change in percentage of IL-12-producing monocytes by intracytoplasmic staining
  • time to first exacerbation
  • number and severity of exacerbations
  • MRI evidence at baseline and Months 12 and 24 of MS progression, as measured by T2 lesion volume, number of enhancing lesions on T1 weighted images, and measurements of atrophy (brain parenchymal fraction, atrophy index)
  • Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores

Estimated Enrollment:   40

Detailed Description:

MS is a chronic inflammatory disease of the central nervous system characterized by focal T cell and macrophage infiltrates that lead to demyelination and loss of neurologic function. Four therapies are currently approved for the treatment of MS. Three of these are approved for the treatment of patients with the relapsing-remitting (RR) form of MS, in which patients have clinical exacerbations followed by partial or complete recovery of function. These treatments are only modestly effective and are associated with significant toxicity, often causing patients to delay therapy for significant lengths of time. Thus, there is a need to find therapies with low toxicities that can be administered early during the disease course with the potential for arresting the disease.

During the pre-treatment phase, patients undergo neurological exams, including the extended disability status scale (EDSS), Ambulation Index (AI), disease steps (DS) scale MS functional composite score, PASAT, 9 hole peg test, and the 25 foot walking time. A 12-lead electrocardiogram (EKG) and chest x-ray are performed. Serum chemistry is assessed as well as electrolyte and thyroid stimulating hormone (TSH) levels. A brain MRI (with and without gadolinium), urinalysis, and urine pregnancy test (for women of reproductive potential) are performed. Blood is collected for mechanistic studies. In the treatment phase, patients are assigned randomly to 1 of 2 study arms:

Arm 1: Copaxone plus placebo. Arm 2: Copaxone plus albuterol. At the treatment visits, blood is collected and neurological exams and a brain MRI are performed. A pregnancy test is administered to women of reproductive potential. Neurological exams are performed every 6 months. MRIs are performed at baseline, Year 1, and Year 2. At the end of the study, patients have a complete physical exam, a neurological exam, and a brain MRI.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039988

Locations
United States, Massachusetts
Brigham and Women's Hospital/Harvard Medical School    
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Investigators
Principal Investigator:     Samia Khoury    
  More Information

Study ID Numbers:   DAIT AMS01, ACE Study #AMS01
First Received:   June 18, 2002
Last Updated:   April 2, 2007
ClinicalTrials.gov Identifier:   NCT00039988
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Outcome  
Multiple Sclerosis  
Albuterol  
Copolymer 1  

Study placed in the following topic categories:
Copolymer 1
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Albuterol
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Immune System Diseases
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Anti-Asthmatic Agents
Reproductive Control Agents
Immunosuppressive Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 05, 2008




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