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Sclerosis clinical trials

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NCT ID: NCT01583088 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation

RespiStimALS
Start date: September 2012
Phase: Phase 3
Study type: Interventional

ALS is is characterized by a progressive degeneration of motor neurons, leading to progressive weakness of muscles, including respiratory muscles, the diaphragm. Although specific therapy is lacking, correct respiratory therapy improves quality of life and increases survival. Substituting the failing respiratory muscles by non invasive mechanical ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic nerve stimulation is a new treatment and has been the object of a preliminary international proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve stimulation in one group and a sham stimulation in the other group. Although, all the patients will be implanted, thus, at the end of the study, all the patients will receive effective stimulation.

NCT ID: NCT01578785 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

GLOW
Start date: March 2012
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

NCT ID: NCT01559129 Terminated - Systemic Sclerosis Clinical Trials

Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease

Start date: August 9, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.

NCT ID: NCT01516554 Terminated - Multiple Sclerosis Clinical Trials

Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

Start date: February 2012
Phase: Phase 2
Study type: Interventional

Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients and is often a significant source of disability. Unlike normal fatigue, multiple sclerosis related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to dysfunction in the neural pathways that regulate the perception of energy although the precise cause is still not understood. While MSRF can be managed through lifestyle modifications and with drug treatment, these measures are commonly either ineffective or only partially effective. Administration of the male sex hormone testosterone has been shown to improve energy levels in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients with other medical conditions not associated with low testosterone levels, suggesting that this treatment may also be useful in symptomatic control of MSRF. This proposed seven-month long clinical trial is designed to test the hypothesis that administration of oral testosterone tablets to male MS patients will result in an improvement of fatigue relative to the administration of placebo tablets. As fatigue is frequently reported by MS patients to be one of their most frustrating and disabling symptoms, any proven additional treatment option for MSRF would be beneficial in improving quality of life.

NCT ID: NCT01499667 Terminated - Clinical trials for Relapsing Remitting Multiple Sclerosis (RRMS)

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

TOFIINGO
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

NCT ID: NCT01474122 Terminated - Systemic Sclerosis Clinical Trials

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

DUAL-2
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU). Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.

NCT ID: NCT01440062 Terminated - Multiple Sclerosis Clinical Trials

Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Start date: December 2011
Phase: Phase 2
Study type: Interventional

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

NCT ID: NCT01436643 Terminated - Depression Clinical Trials

Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

REGAIN
Start date: November 2011
Phase: Phase 4
Study type: Interventional

This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.

NCT ID: NCT01435993 Terminated - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

Start date: September 8, 2011
Phase: Phase 1
Study type: Interventional

This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.

NCT ID: NCT01428505 Terminated - Multiple Sclerosis Clinical Trials

[18F]PBR111 and Microglial Activation in Multiple Sclerosis

Start date: July 2011
Phase: Phase 2
Study type: Interventional

This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers.