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Multiple Sclerosis clinical trials

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NCT ID: NCT00079495 Completed - Multiple Sclerosis Clinical Trials

Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)

Start date: July 2003
Phase: Phase 2
Study type: Interventional

We are studying this investigational drug treatment, comparing it with placebo, to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects. The investigational drug will be administered in the clinic weekly for 5 injections (induction phase) then monthly for 8 additional injections (maintenance phase). Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years, with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study.

NCT ID: NCT00078338 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Start date: February 16, 2004
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

NCT ID: NCT00076934 Completed - Multiple Sclerosis Clinical Trials

Safety of RG2077 in Patients With Multiple Sclerosis

Start date: January 2003
Phase: Phase 1
Study type: Interventional

Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS. Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and decrease accumulation of lesions on MRI.

NCT ID: NCT00071838 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis

Start date: October 30, 2003
Phase: Phase 2
Study type: Interventional

This study will examine the safety of Zenapax (daclizumab) in patients with multiple sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes (cells of the immune system), are thought to damage myelin, a substance that covers the nerve and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin that occurs in multiple sclerosis. Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this study. Patients with secondary-progressive or primary progressive MS may not participate. Candidates will be screened with a complete neurological and medical evaluation and review of medical records. Participants will undergo the following tests and procedures: - Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over a 3-month period to assess disease activity. For the MRI scans, the patient lies on a table that slides into the scanner - a narrow metal cylinder with a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Only patients with activity at or above a certain level are eligible to continue with the treatment phase of the study. - Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax. The first two infusions are 2 weeks apart, followed by 13 monthly infusions. - MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease activity and identify new brain lesions. - Blood and urine tests: Blood and urine samples are collected at each clinic visit for routine laboratory evaluations, immunologic study, and genetic testing to determine a predisposition for responding to Zenapax treatment. - Lumbar puncture (spinal tap): This procedure will be done during the last month before starting treatment and during the seventh month of treatment to examine immune changes that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the brain and spinal cord. A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. - Skin test: A needle is placed just under the skin is done to assess the patient's immune status to common antigens such as tetanus, mumps and candida. - Lymphocytopheresis: Lymphocytes are collected three times - once during the last month of baseline before starting treatment, once during the fifth month of treatment, and once during the last month of treatment - for immunologic study. Blood is collected through a needle in an arm vein in a similar way to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The lymphocytes are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body, either through the same needle or through another needle in the other arm.

NCT ID: NCT00067327 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Treatment of Multiple Sclerosis Using Over the Counter Inosine

Start date: February 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether raising low levels of the natural antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary progressive Multiple Sclerosis (MS).

NCT ID: NCT00064909 Completed - Multiple Sclerosis Clinical Trials

MR Perfusion Imaging and Hypercapnia (Increased Carbon Dioxide) to Study New Blood Vessel Formation in Multiple Sclerosis

Start date: July 2003
Phase: N/A
Study type: Observational

This study will use magnetic resonance imaging (MRI) to examine and compare changes in blood flow and blood volume in the brains of normal volunteers and patients with multiple sclerosis (MS). Patients with MS-an inflammatory disease that attacks the brain and spine-may have new blood vessel formation (called angiogenesis) within the brain that may or may not contribute to the disease or help in repairing the brain. It is not known if these new vessels behave in the same way as the naturally occurring vessels. MRI uses a strong magnetic field and radio waves to generate brain images that provide information on brain chemistry, function, and blood flow. The results of this study may lead to a better understanding of MS. Healthy normal volunteers and patients with multiple sclerosis 18 years of age and older may be eligible for this study. Normal volunteers must have no history of signs or symptoms of central nervous system disease. Patients with MS will be recruited from the NIH Neuroimmunology MS clinic. All participants will undergo MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner). Scanning varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. During the scan, the subject wears earplugs to muffle loud knocking noises caused by electrical switching of the radio frequency circuits. The subject can communicate with the MRI staff at all times during the procedure. During the scan, the subject wears a mask and breathes in room air or air containing 6% carbon dioxide (CO2). (Room air contains approximately 0.04% CO2, which is about 150 times less than the 6% CO2. Air that is normally breathed out contains about 5% CO2.) Breathing 6% CO2 increases the amount of blood flow in the brain that can be measured using MRI. The total duration of a single 6 percent CO2 inhalation will not exceed 10 minutes. A catheter (thin plastic tube) is placed in a vein in the subject's arm before he or she enters the scanner. At some point during the scan, a contrast agent called gadolinium DTPA is injected into the vein through the catheter. This agent enables clearer images of the brain.

NCT ID: NCT00062972 Withdrawn - Multiple Sclerosis Clinical Trials

Improving Memory in Patients With Multiple Sclerosis

Start date: September 1999
Phase: Phase 3
Study type: Interventional

People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer's disease.

NCT ID: NCT00053417 Completed - Multiple Sclerosis Clinical Trials

Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Start date: February 2003
Phase: Phase 2
Study type: Interventional

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

NCT ID: NCT00050778 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

Start date: December 2002
Phase: Phase 2
Study type: Interventional

This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.

NCT ID: NCT00050232 Completed - Multiple Sclerosis Clinical Trials

Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

Start date: December 2002
Phase: Phase 3
Study type: Interventional

Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.