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NCT ID: NCT01462318 Active, not recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

An Immunogenicity and Pharmacokinetics (PK) Study of BIIB019 (Daclizumab High Yield Process (DAC HYP)) Prefilled Syringe in Relapsing Remitting Multiple Sclerosis (RRMS)

OBSERVE
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetic (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).

NCT ID: NCT01348451 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis

ALS
Start date: January 2009
Phase: Phase 1
Study type: Interventional

This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see if the cells and the procedure to transplant them are safe.

NCT ID: NCT01339676 Active, not recruiting - Multiple Sclerosis Clinical Trials

Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

Start date: March 2008
Phase: Phase 4
Study type: Interventional

This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.

NCT ID: NCT01303770 Active, not recruiting - Multiple Sclerosis Clinical Trials

Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

Start date: February 2011
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age. Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation. The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.

NCT ID: NCT01228396 Active, not recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis

AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

Start date: May 2009
Phase: Phase 2
Study type: Interventional

Patients with marked bladder dysfunction as a result of secondary progressive multiple sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in this double-blind crossover study.

NCT ID: NCT01220830 Active, not recruiting - Multiple Sclerosis Clinical Trials

Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonance Therapy for Multiple Sclerosis

RFQMR
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in cases of Multiple sclerosis. The evaluation will be done based on MRI findings, by clinical/ neurological examination and by assessment of quality of life before and after completion of therapy.

NCT ID: NCT01212094 Active, not recruiting - Multiple Sclerosis Clinical Trials

Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid). Objectives: - To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab in individuals with secondary-progressive multiple sclerosis. Eligibility: - Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been off any form of immunosuppressive therapy for at least 3 months. Design: - The study will involve a 1-year pretreatment baseline series of visits, followed by a 2-year treatment period. Participants will provide blood samples throughout treatment as directed by the study researchers, and additional studies may be performed during the study period if participants consent to further investigation. - Baseline Visits: - Visit 1: Participants will provide blood samples and have a magnetic resonance imaging (MRI) scan of the brain. - Visits 2 and 3: In addition to providing blood samples, participants will have an MRI scan of the spine, additional tests of vision and motor skills, and a lumbar puncture to collect a sample of cerebrospinal fluid. Participants will be randomly assigned to receive either rituximab or a placebo. - Visit 4: In addition to providing blood samples, participants will have an MRI scan of the brain and a skin biopsy. - Treatment Visits: - Visit 5: Participants will be admitted for a 2-day inpatient stay, and will have MRI scans, vision and motor skills tests, and blood samples on the first day. On the second day, participants will receive rituximab or placebo by both intravenous drip and through a lumbar puncture, and will be discharged on the following day after overnight monitoring. - Visit 6: Two weeks after Visit 5, participants will have an overnight stay to receive rituximab or placebo by intravenous drip only. - Visit 7: Six months after Visit 6, participants will have MRI scans and provide blood samples. - Visit 8: One year after Visit 5, participants will have another 2-day inpatient stay. On the first day, the same procedures performed described for Visit 5 will be repeated; on the second day, participants will receive rituximab or placebo through a lumbar puncture only, and will be discharged on the following day after overnight monitoring. - Visit 9: Six months after Visit 8, participants will have MRI scans and provide blood samples. - Visit 10: Six months after Visit 9, participants will have MRI scans and provide blood samples. - After the end of the study, participants will continue with standard care for SP-MS.

NCT ID: NCT01081275 Active, not recruiting - Multiple Sclerosis Clinical Trials

Improving Hand Use in Multiple Sclerosis

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.

NCT ID: NCT01042158 Active, not recruiting - Clinical trials for Pulmonary Hypertension

A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis

ATPAHSS
Start date: January 2010
Phase: Phase 4
Study type: Interventional

This will be a 36-week, randomized, double-blind, parallel group study comparing the effects of tadalafil monotherapy, ambrisentan monotherapy and combination therapy with tadalafil and ambrisentan in patients with PAH-SSc. Standard outcome measures such as six-minute walk distance (6MWD), NYHA classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo-placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.

NCT ID: NCT00886977 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).