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Sclerosis clinical trials

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NCT ID: NCT03919799 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams [mg] once daily [QD] and 200 mg twice daily [BID]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.

NCT ID: NCT03870763 Terminated - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

Start date: March 19, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.

NCT ID: NCT03836716 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.

NCT ID: NCT03808545 Terminated - Multiple Sclerosis Clinical Trials

Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

ABC's of MS
Start date: February 26, 2019
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the U.S. Cardiometabolic risk factors including obesity and hyperlipidemia are common among people with MS, and these risk factors are associated with severity and frequency of MS relapses and disease progression. People with MS often experience symptoms of pain, fatigue, and depression, which make adhering to a healthy lifestyle difficult, as evidenced by the high rates of unhealthy behaviors including poor diet and physical inactivity among this group. Physical activity has reduced symptoms of MS and improved metabolic risk profiles, but little research has focused on the role of a dietary intervention combined with physical activity in this group. Therefore, the purpose of this study is to test the efficacy of a combined diet and physical activity intervention for reducing cardiometabolic risks and MS symptoms when compared to a physical activity intervention alone.

NCT ID: NCT03774914 Terminated - Multiple Sclerosis Clinical Trials

LEMTRADA Pregnancy Registry in Multiple Sclerosis

Start date: September 1, 2015
Phase:
Study type: Observational [Patient Registry]

Primary Objective: The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis. Secondary Objective: The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.

NCT ID: NCT03759249 Terminated - Multiple Sclerosis Clinical Trials

Sleep Medical Treatment in MS Patients Suffering From Fatigue

Sleep-in-MS
Start date: December 8, 2015
Phase: N/A
Study type: Interventional

This study evaluates the effect of an extensive sleep medical investigation and of the subsequent treatment on multiple sclerosis (MS) related fatigue (provided a previously unknown sleep disorder was found).

NCT ID: NCT03757351 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis

Start date: December 14, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis in a cross-over design

NCT ID: NCT03723356 Terminated - Multiple Sclerosis Clinical Trials

Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)

Start date: July 1, 2018
Phase:
Study type: Observational

Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.

NCT ID: NCT03693118 Terminated - Multiple Sclerosis Clinical Trials

Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients

Start date: January 13, 2018
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a chronic demyelinating disease of the central nervous system leading to the impairment of motor, visual and cognitive functions. A standardized rehabilitation of cognitive functions can be provided by a systematized treatment program devised to improve neurological patients' quality of life. The degree of difficulty of the computerized tasks was adapted to a patient's predispositions and modified once a desirable improvement in the practiced skill has reached. The aim of the study was to assess the influence of cognitive therapy by means of the cognitive software on manual dexterity in patients with multiple sclerosis. We also attempted to establish whether factors like age, sex and Expanded Disability Status Scale (EDSS) scores contribute to the outcomes of that therapy. All patients enrolled will have a documented history of MS disease prior to study enrollment. The EDSS scores varied between 1.5-4 (mean score 2.1). The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break. Having completed the training each patient was administered the NHPT test again in view of assessing the efficiency of their upper limb. Due to progressive deterioration of health and other factors only 10 patients managed to complete the training.

NCT ID: NCT03679975 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)

ROSF
Start date: April 4, 2018
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the effect, if any, of a single 50 mg dose of Riluzole Oral Soluble Film (ROSF) on swallowing safety in individuals with amyotrophic lateral sclerosis.