Treatment of Multiple Sclerosis With Copaxone and Albuterol

NCT00039988 | Completed

• 2 other identifiers: DAIT AMS01ACE Study AMS01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Diseases; Multiple Sclerosis

Keywords

Treatment Outcome; Multiple Sclerosis; Albuterol; Copolymer 1

Outcome Measures

Primary Outcomes (2)

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

  Throughout study

• 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

Secondary Outcomes (6)

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

  Throughout study

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

  Throughout study

• 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

Study Arms (2)

1

EXPERIMENTAL

Participants will receive Copaxone and albuterol placebo

Drug: Glatiramer acetate; Drug: Albuterol placebo

2

EXPERIMENTAL

Participants will receive Copaxone and albuterol

Drug: Glatiramer acetate; Drug: Albuterol

Interventions

Glatiramer acetate DRUG

20 mg administered subcutaneously daily

1; 2

Albuterol DRUG

2 mg or 4 mg oral capsules taken daily

2

Albuterol placebo DRUG

Oral placebo capsules will be taken daily

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Autoimmunity Centers of Excellence: collaborator

Study Sites (1)

Brigham and Women's Hospital/Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Khoury SJ, Healy BC, Kivisakk P, Viglietta V, Egorova S, Guttmann CR, Wedgwood JF, Hafler DA, Weiner HL, Buckle G, Cook S, Reddy S. A randomized controlled double-masked trial of albuterol add-on therapy in patients with multiple sclerosis. Arch Neurol. 2010 Sep;67(9):1055-61. doi: 10.1001/archneurol.2010.222.

  PMID: 20837847 RESULT

MeSH Terms

Conditions

Autoimmune Diseases; Multiple Sclerosis

Interventions

Glatiramer Acetate; Albuterol

Condition Hierarchy (Ancestors)

Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Samia Khoury

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2002
• First Posted: June 20, 2002
• Study Start: November 1, 2001
• Primary Completion: March 1, 2006
• Study Completion: November 1, 2007
• Last Updated: September 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)