|
Treatment of Multiple Sclerosis with Copaxone and Albuterol Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Treatment of Multiple Sclerosis with Copaxone and Albuterol conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Treatment of Multiple Sclerosis with Copaxone and Albuterol Clinical research trials and Treatment of Multiple Sclerosis with Copaxone and Albuterol health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Treatment of Multiple Sclerosis with Copaxone and Albuterol. Treatment of Multiple Sclerosis with Copaxone and Albuterol Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Treatment of Multiple Sclerosis with Copaxone and Albuterol clinical trial. Subjects frequently get the best healthcare possible for their Treatment of Multiple Sclerosis with Copaxone and Albuterol condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Multiple Sclerosis with Copaxone and Albuterol  Treatment of Multiple Sclerosis with Copaxone and Albuterol
Treatment of Multiple Sclerosis with Copaxone and Albuterol
For Condition: Multiple Sclerosis,Autoimmune Diseases
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the effects of 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
SamiaKhoury, Principal Investigator,
Brigham and Women's Hospital/Harvard Medical School *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Sandra Cook 617-713-2006
Additional Information:
Study ID Numbers: DAIT AMS01; ACE Study #AMS01
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039988
Other Multiple Sclerosis Studies:
1. Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
2. Study of Silicone-Associated Connective Tissue Diseases
3. Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
4. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
5. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
Related Studies:
Other Multiple Sclerosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Treatment of Multiple Sclerosis with Copaxone and Albuterol
|
|
|
|
|
|
|
|
