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Sclerosis clinical trials

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NCT ID: NCT05029609 Withdrawn - Multiple Sclerosis Clinical Trials

Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS

Start date: October 2021
Phase: Phase 1
Study type: Interventional

The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.

NCT ID: NCT04925778 Withdrawn - Clinical trials for Relapsing Remitting Multiple Sclerosis

Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate

PERSIST
Start date: June 30, 2021
Phase:
Study type: Observational

This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®.

NCT ID: NCT04880577 Withdrawn - Fatigue Clinical Trials

Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis

Start date: September 15, 2022
Phase: Phase 2
Study type: Interventional

As the in vivo reservoir of the Epstein-Barr virus, B cells play an important role in the perpetuation of MS disease activity. B cell depletion therapy with medications like ocrelizumab or rituximab have proved very successful in preventing clinical relapses and MRI activity in MS, but incomplete in terms of neuroprotection and symptomatic outcomes. Ocrelizumab and rituximab only target naïve and memory B cells expressing the CD20 marker but do not deplete the wide spectrum of B cell lineages including plasmablasts and plasma cells, which are also key reservoirs for EBV. This is particularly relevant to the mechanism of action of TAF, since EBV lytic reactivation occurs in coordination with B-cell differentiation. In vivo, the initiation of plasma cell differentiation provides the physiological trigger for EBV lytic reactivation, and EBV utilizes the plasma cell differentiation program to replicate. As these cells are ineffectively depleted by anti-CD20 treatment, the use of TAF would be highly complementary as an add-on treatment to anti-CD20 therapy. Anti-EBV therapy with TAF in combination with ocrelizumab or rituximab will therefore provide a synergistic approach to cover the whole EBV reservoir. The primary aims of the proposed trial are to determine if TAF, at the standard dose of 25 mg/day administered for 12 months: i) is safe and well-tolerated by individuals with RRMS over a period of treatment of 12 months; ii) leads to an overall improvement in fatigue, as assessed by the Modified Fatigue Impact Scale by 12 months; and iii) causes a reduction in serum concentrations of neurofilament light chain (NfL), a marker of neuronal damage in MS.

NCT ID: NCT04764383 Withdrawn - Multiple Sclerosis Clinical Trials

Histaminergic Basis of Fatigue in Multiple Sclerosis

Start date: January 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to identify a way to improve the feeling of exhaustion that patients might experience because of Multiple Sclerosis (MS).

NCT ID: NCT04578041 Withdrawn - Multiple Sclerosis Clinical Trials

TRPMS to Improve Mobility and Depression in Multiple Sclerosis

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This study is aimed to test the efficacy of 10 sessions of Transcranial Rotating Permanent Magnetic Stimulation (TRPMS) paired with aerobic exercise or computerized cognitive training (CT) on mobility and depression symptoms in 40 individuals affected by multiple sclerosis (MS). Participants in Arm 1 will complete 10x40 minutes daily sessions of TRPMS+aerobic exercise. Participants in Arm 2 will complete TRPMS+computerized CT. Primary outcomes for both arms will be assessed at baseline, at treatment end and after 4-week from the treatment end (follow-up).

NCT ID: NCT04505358 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Evaluate PU-AD in Subjects With Amyotrophic Lateral Sclerosis

ALS
Start date: January 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase 2a, randomized, double-blind, placebo-controlled pilot study to assess the biological activity, safety and pharmacokinetics of PU-AD compared to placebo in ALS. It will be conducted in approximately 20 sites in the US. Approximately 30 subjects will be enrolled in this study; subjects will be randomized 3:2 to receive either PU-AD 30 mg or matching placebo qd, added onto any current stable background treatment.

NCT ID: NCT04468191 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

Fatigue in Patients With Amyotrophic Lateral Sclerosis

Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Expiratory muscle strength training (EMST) is an emerging palliative intervention for prolonging pulmonary and swallow function in patients with amyotrophic lateral sclerosis (PALS), but it is unknown whether EMST may result in detrimental immediate to short-term fatigue because there is no way to measure fatigue non-invasively. This study will determine the immediate to short-term impact of EMST on objective respiratory and swallow function, whether subjective ratings of dyspnea and fatigue map to objective decompensation of respiratory and swallow function, and the ability to monitor fatigue of the respiratory and swallowing musculature non-invasively. Findings from this research study will provide preliminary evidence regarding optimal timing for PALS to complete EMST and will provide PALS and clinicians increased capabilities to monitor fatigue non-invasively.

NCT ID: NCT04445116 Withdrawn - Multiple Sclerosis Clinical Trials

Endeavorâ„¢ in Pediatric MS

Akili
Start date: January 2023
Phase: N/A
Study type: Interventional

This study will examine the feasibility of using an Endeavorâ„¢ application as a treatment modality for cognitive impairments in the pediatric MS population. Participants will be asked to undergo a hour-long baseline evaluation, followed by at-home Endeavorâ„¢ application sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at the end of the study. They will undergo another hour-long follow-up evaluation at the end of the study.

NCT ID: NCT04390386 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

Controlled Study of IC14 for Treatment of ALS

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

The ALS IC14 Trial is a multi-center, placebo-controlled clinical trial evaluating the safety and efficacy of IC14 for the treatment of ALS

NCT ID: NCT04344626 Withdrawn - Stroke Clinical Trials

Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery

Start date: July 16, 2018
Phase: N/A
Study type: Interventional

Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. In such cases, surgery is the treatment of choice. Complete resection of affected brain tissue is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods are of limited use. An important subjective assessment during surgery is that affected brain tissue feels stiffer, however there is presently no way to determine this without committing to resecting the affected area. It is hypothesized that intra-operative use of a tonometer (Diaton) will identify abnormal brain tissue stiffness in affected brain relative to normal brain. This will help identify stiffer brain regions without having to resect them. The objective is to determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying epileptogenic lesions. In participants with refractory epilepsy, various locations on the cerebral cortex will be identified using standard pre-operative investigations like magnetic resonance imagin (MRI) and positron emission tomography (PET). These are areas of presumed normal and abnormal brain where the tonometer will be used during surgery to measure brain tissue stiffness. Brain tissue stiffness measurements will then be compared with results of routine pre-operative and intra-operative tests. Such comparisons will help determine if and to what extent intra-operative brain tissue stiffness measurements correlate with other tests and help identify epileptogenic brain tissue. 24 participants have already undergone intra-operative brain tonometry. Results in these participants are encouraging: abnormally high brain tissue stiffness measurements have consistently been identified and significantly associated with abnormal brain tissue. If the tonometer adequately identifies epileptogenic brain tissue through brain tissue stiffness measurements, it is possible that resection of identified tissue could lead to better post-operative outcomes, lowering seizure recurrences and neurological deficits.