Ongoing research trials in neurology:
WHAT YOU NEED TO KNOW ABOUT ON-GOINGNEURO RESEARCH TRIALS IN 202
-Sai Lavanya Patnala, Intern, Apollo Institute of Medical Sciences and Research, Hyderabad
INTRODUCTION
The year 2022 brought some new drugs into the light, like Lecanemab, a humanized IgG1 monoclonal antibody that binds with high affinity to Aβ soluble protofibrils, which showed efficacy in people with mild cognitive impairment or incipient Alzheimer’s disease, and Daridorexant, a dual orexin antagonist with no risk of addiction that showed efficacy in sleeping disorders.
The most debated aspect of multiple sclerosis research came from a large study using a Veterans Administration database that showed that an Epstein-Barr virus infection clearly increased a person’s risk of developing multiple sclerosis.
In the field of stroke, two randomized trials showed that mechanical thrombectomy is superior to medical treatment in people with thrombosis or occlusion of the basilar artery.
Some monoclonal antibodies against CGRP or CGRP receptors with almost no side effects were also found to be effective in treating chronic migraines, especially in those who have had prior treatments that failed and in those with medication overuse headaches.
Let’s take a deep dive into some of the ongoing studies in 2023.
DRUG TRIALS
A small study at Vanderbilt University Medical Center, Trigeminal, Tennessee, being done in patients with trigeminal neuralgia, is working on evaluating the efficacy of guanfacine in reducing acute pain and extending the duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, as measured by Visual Analog Scale data collected after each injection.
Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how. Emory University is evaluating the use of clarithromycin for treating sleepiness in two related conditions: narcolepsy without cataplexy and idiopathic hypersomnia. This study will look at brain activity using MRI and EEG, inflammation, gut bacteria, and CSF to better understand how clarithromycin can reduce sleepiness.
At the University Medical Centre Ljubljana, Slovenia, researchers are conducting a double-blind, placebo-controlled, cross-over study among children with severe spasticity related to cerebral palsy, levels IV and V, with a full-spectrum medical cannabis product called HemPhar with a CBD/THC ratio of 10:1.
NEWER MODALITIES OF THERAPY IN PSYCHIATRY
The University of Texas Health Science Center, Houston, is currently working on Reclaim: Deep Brain Stimulation (DBS) Therapy for patients with chronic, severe OCD, which has proven resistant to primary pharmacological and/or behavior therapy options using a lead stereotactically introduced into the anterior insular cortex.

Another study at Emory University called SO-PTSD (Sympathetic Overactivity in Post-traumatic Stress Disorder) is testing if device-guided slow breathing or transcutaneous vagal nerve stimulation improves vascular function and SNS activity at rest and during stress in people with PTSD.
ON-GOING TRIALS IN RADIOLOGICAL DIAGNOSIS
In a case-control study being done at the Washington School of Medicine, a brain imaging method called Pittsburgh B (PIB) Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET is being used to identify individuals with Parkinson’s disease who are at risk of developing dementia and determine dementia subtypes in these patients.
The Central Vein Sign in MS (CAVS-MS) study was done by researchers from the Cleveland Clinic and Cedars-Sinai Medical Center to assess the sensitivity and specificity of the Central Vein Sign (CVS) criteria. The study is enrolling a mixed population of patients with typical and atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms, across North America.

ON-GOING BIOMARKER STUDIES
Patients with Parkinson’s disease, multiple system atrophy, and progressive supranuclear palsy are being compared for the BIOPARK (Biomarkers in Parkinsonian Syndromes) study at University Hospital, Bordeaux. These biological markers will be crucial for future disease modification and neuroprotection trials.
Researchers from the Mayo Clinic and the University of California, San Francisco are conducting the Neurofilament Surveillance Project (NSP) to collect blood samples and analyze plasma neurofilament light chain (NfL) levels longitudinally during disease onset and progression in people with known familial frontotemporal lobar degeneration (f-FTLD) mutations in comparison to a control group of people without known f-FTLD mutations.

SPECIAL MENTION OF NEW ALZHEIMER’S DRUG
Ionis Pharmaceuticals, Inc., and Biogen recently presented their latest Phase 1b clinical data at the International Conference on Alzheimer’s and Parkinson’s Diseases, demonstrating that IONIS-MAPTRx (BIIB080) reduced aggregated tau pathology as assessed by positron emission tomography (PET) and soluble tau protein in cerebrospinal fluid (CSF) in patients with early-stage Alzheimer’s disease (AD) in a dose-dependent and sustained manner.

-Sai Lavanya Patnala, Intern, Apollo Institute of Medical Sciences and Research, Hyderabad
REFERENCES
- Christopher H. van Dyck et al. Lecanemab in Early Alzheimer’s Disease. January 5, 2023. N Engl J Med 2023; 388:9-21. DOI: 10.1056/NEJMoa2212948. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
- Hans-Christoph Diener. 2022’s Most Important Neurology Studies – Medscape – Dec 30, 2022. Available from: https://www.medscape.com/viewarticle/985738#vp_2
- https://www.centerwatch.com/clinical-trials/listings/232420/efficacy-of-guanfacine-and-lidocaine-combination-in-trigeminal-nerve-block-for-pain-management-in-trigeminal-neuropathy/?&query=acute-pain&rnk=9
- https://www.centerwatch.com/clinical-trials/listings/244271/clarithromycin-mechanisms-in-hypersomnia-syndromes/?sort_by=most_viewed&page=2&query=parkinsons-disease&rnk=12
- https://www.centerwatch.com/clinical-trials/listings/257634/full-spectrum-medical-cannabis-for-treatment-of-spasticity-in-patients-with-severe-forms-of-cerebral-palsy/?sort_by=most_viewed&page=33&query=cerebral-palsy&rnk=198
- https://www.ohsu.edu/brain-institute/understanding-deep-brain-stimulation-dbs
- https://www.centerwatch.com/clinical-trials/listings/166624/sympathetic-overactivity-in-post-traumatic-stress-disorder/?sort_by=most_viewed&page=5&query=cerebral-palsy&rnk=45
- https://clinicaltrials.gov/ct2/show/NCT02763683?term=%22Washington+University+in+St.+Louis%22+OR+%22Barnes-Jewish+Hospital%22&cond=Aging+OR+Dementia+AND+%22Parkinson+Disease%22&draw=2&rank=2
- https://clinicaltrials.gov/ct2/show/NCT04495556?term=%22Washington+University+in+St.+Louis%22+OR+%22Barnes-Jewish+Hospital%22
- https://www.nature.com/articles/nrneurol.2016.166
- https://www.centerwatch.com/clinical-trials/listings/166222/biomarkers-in-parkinsonian-syndromes/?sort_by=most_viewed&page=3&query=parkinsons-disease&rnk=9
- https://clinicaltrials.gov/ct2/show/NCT04516499?term=%22Washington+University+in+St.+Louis%22+OR+%22Barnes-Jewish+Hospital%22&cond=Aging+OR+Dementia+AND+%22Neurobehavioral+Manifestations%22&draw=2&rank=5
- https://www.allftd.org/nsp
- https://www.prnewswire.com/news-releases/new-data-presented-at-adpd2023-show-ionis-mapt-rx-biib080-substantially-reduced-tau-protein-in-patients-with-early-stage-alzheimers-disease-301784211.html