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Sclerosis clinical trials

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NCT ID: NCT03708718 Completed - Systemic Sclerosis Clinical Trials

Prednisolone in Early Diffuse Systemic Sclerosis

PRedSS
Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within 3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years. Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months. Please note: From August 2020, the trial was re-started following halt due to Covid-19 as open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at study exit.

NCT ID: NCT03708276 Completed - Multiple Sclerosis Clinical Trials

My MS Toolkit: a Symptom Self-management Program for Multiple Sclerosis

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis. This study is evaluating various aspects of My MS Toolkit and how it impacts symptom self-management in multiple sclerosis. The research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.

NCT ID: NCT03706391 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Study of ALS Reversals 4: LifeTime Exposures

StARLiTE
Start date: September 26, 2018
Phase:
Study type: Observational [Patient Registry]

Hypothesis: There exists patients who have met ALS or PMA diagnostic criteria and subsequently experienced robust and sustained improvement, i.e. a "reversal." Thirty-eight of these patients were identified in the prior Duke University study, Documentation of Known ALS Reversals (St.A.R. Protocol 1, Duke IRB Pro00076395). The investigators hypothesize these patients have had different environmental exposures than patients with typically progressive ALS. Identification of specific environmental influences may point to exposures which are protective or exposure that lead to the development of a rare and novel reversible ALS-like disease. Objective: This study seeks to identify environmental exposures associated with ALS reversals.

NCT ID: NCT03706131 Completed - Multiple Sclerosis Clinical Trials

The Effect of Cervical Mobilization on Balance and Spasticity in Multiple Sclerosis Individuals

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.

NCT ID: NCT03705390 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS)

ALS
Start date: March 29, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II study to determine the safety and tolerability of ILB , a type of low molecular weight dextran sulfate, in patients with Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT03693781 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Colchicine for Amyotrophic Lateral Sclerosis

Co-ALS
Start date: April 10, 2019
Phase: Phase 2
Study type: Interventional

The study evaluates the effects of two different Colchicine doses (0.01mg/kg/day or 0.005 mg/kg/day) compared to placebo in Amyotrophic Lateral Sclerosis (ALS) patients. Disease progression as defined by changes in ALSFRS-r is the primary outcome measure. Other measures of clinical progression and survival, together with safety and tolerability of Colchicine in ALS patients will be assessed.

NCT ID: NCT03692975 Completed - Multiple Sclerosis Clinical Trials

MRI Hippocampal Microstructure and Episodic Memory in Early Multiple Sclerosis

Micro-MS
Start date: February 12, 2019
Phase: N/A
Study type: Interventional

Clinically isolated syndrome (CIS) can evolve into multiple sclerosis. In CIS patients, episodic memory is frequently impaired. Memory disorders could be preceded by microstructural abnormalities without visible atrophy in hippocampus. A recent MRI imaging of diffusion called NODDI (Neurite Orientation Dispersion and Density Imaging) can measure specifically microstructural abnormalities and map the axons in the white matter (WM) and dendrites in the grey matter (GM). The aim of this study is to evaluate microstructural abnormalities in the dentate gyrus of the hippocampus in CIS patients compared to controls.

NCT ID: NCT03692299 Completed - Systemic Sclerosis Clinical Trials

Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Introduction. Autonomic dysfunction, smooth muscle fibrosis and vascular damage lead to small intestinal bacterial overgrowth (SIBO) in Systemic Sclerosis (SSc). SIBO is characterized by diarrhea, abdominal pain, bloating, malabsorption and malnutrition. Aim. To evaluate the efficacy and safety of Saccharomyces boulardii in combination with metronidazole for 2 months for reducing gastrointestinal symptoms (NIH-PROMIS) and preventing bacterial overgrowth (hydrogen breath test) versus the standard treatment in patients with systemic sclerosis. Method. Controlled clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. NIH PROMIS®questionarie will be apply to evaluate gastrointestinal symptoms and classify in not symptomatic, least, mildy, moderately and most symptomatic. Glucose HBT will be apply after 14 hours fast, oral hygiene and 30 days free of antibiotics to evaluate SIBO. Patients with negative HBT and symptoms associated to glucose ingestion will repeat test with lactulose. Patients will be aleatorized into 1. Saccharomyces boulardii, 2. Metronidazole and 3. Metronidazole plus Saccharomyces boulardii. All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.

NCT ID: NCT03691766 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Photobiomodulation Therapy in Persons With Multiple Sclerosis

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

This study will test whether photobiomodulation therapy improves muscle endurance and decreases inflammation in persons with relapsing-remitting multiple sclerosis. We will also investigate mechanisms for any improvements.

NCT ID: NCT03689972 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks [Q6W]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks [Q4W]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.