Neurología

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Synucleinopathies

   Rochester, Minn.

   The goals of the study are to prospectively evaluate clinical and laboratory biomarkers of multiple system atrophy and Parkinson’s disease at early clinical disease, at a premotor stage (PAF), and even at a prodromal stage (RBD).

2. A Study to Analyze NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I),  and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

3. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU

   Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).

4. A Study of Factors That Predispose, Promote, and Perpetuate Post-Traumatic Dizziness

   Rochester, Minn.

   The purpose of this study is to investigate whether recent, groundbreaking discoveries about key pathophysiologic processes that drive chronic dizziness in patients without traumatic brain injury (TBI9,10) are applicable to patients with post-mTBI vestibular disability. We expect the results of this project to have practical clinical and research applications, providing novel data for two future steps:

5. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

   Rochester, Minn., Jacksonville, Fla.

   We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

6. A Study to Evaluate Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders

   Rochester, Minn.

   The purposes of this study are to explore the association between female sex, reproductive history and clinical phenotypic variability in multiple sclerosis (MS), to explore the association between female sex, reproductive history and radiologic phenotypic variability in MS, and to explore the association between female sex, genetic and environmental interactions in MS.

    

7. A Study to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection Using Intraoperative Brain Microdialysis

   Rochester, Minn.

   The purpose of this study is to measure the space and time characteristics of inflammatory mediator release in response to induced epileptiform activity in ASD-resistant patients.

8. PLS Natural History Study

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to develop a natural history dataset and biorepository of early Primary Lateral Sclerosis (PLS) and well-established PLS cases for future clinical trials.

9. A Study to Develop and Assess the Role of Artificial Intelligence in MR Fingerprinting of the Brain

   Rochester, Minn.

   The purpose of this study is to develop an artificial intelligence (AI) system than can process MR images acquired using conventional acquisition schemes (spin echo, gradient echo, etc) and contrasts (T1, T2, T2*, PD) to identify the MR fingerprint of the tissue under interrogation.

10. A Study to Evaluate MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with Amyotrophic Lateral Sclerosis (ALS)

    Jacksonville, Fla.

    The purpose of this study is to evaluate the effectiveness, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.