SPARC (Sun Pharma)/K0706 (NCT03655236):
This study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. K0706 works to suppress an enzyme called Abl tyrosine kinase, whose activity has been linked to several processes associated with Parkinson’s development, such as oxidative stress and alpha-synuclein-induced neurodegeneration.
https://www.proseekstudy.com/
https://clinicaltrials.gov/ct2/show/results/NCT03655236
This is a phase III randomized, active-controlled trial designed to assess the efficacy and safety of treatment with continuous subcutaneous ND0612 (a novel liquid formulation of levodopa/carbidopa) in comparison to oral immediate-release levodopa/carbidopa in patients with PD experiencing motor fluctuations.
https://www.boundless-study.com/Public
ADDEX/ADX48621 (NCT04857359)
This study is to evaluate the efficacy of ADX48621, dipraglurant, on levodopa-induced dyskinesias (LID). Dipraglurant is a new oral small molecule that inhibits the metabotropic glutamate receptor 5 (mGluR5), which has been shown to play a role in LID.
https://clinicaltrials.gov/ct2/show/NCT04857359
https://www.addextherapeutics.com/en/pipeline/researches/dipraglurant-pd-lid/
Contera Pharma and Bukwang/SHINE study
This study is to evaluate the efficacy of JM-010, a combination of two serotonin agonists, on levodopa-induced dyskinesias (LID). The serotoninergic system is thought to play a role in LIDs due to loss of the normal mechanisms in dopamine regulation
https://clinicaltrials.gov/ct2/show/NCT04377945
Rutgers – High Fiber in Parkinson’s disease
The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans.
https://clinicaltrials.gov/ct2/show/NCT04976959
Rutgers - Parkinson Disease and DBS (deep brain stimulation): Cognitive Effects in GBA Mutation Carriers
This study will examine the relationship between glucocerebrosidase (GBA) gene mutations and subthalamic nucleus (STN) DBS and its impact on cognition. Studies suggest that PD patients with mutations in the GBA gene are at higher risk for cognitive impairment and ~10-17% of patients who undergo DBS carry the GBA mutation. There may be an interaction between STN-DBS and GBA resulting in worsened cognitive function. This project aims to 1) determine the relationship between GBA mutation status and post-op STN-DBS function, 2) broaden genotype-phenotype relationships of GBA mutation carriers and 3) provide data on longitudinal cognitive effects of DBS in GBA mutation carriers.
https://clinicaltrials.gov/ct2/show/NCT03234478
ABBVIE/PROSPECT study
Observational study looking at patients with motor fluctuations and evaluating their quality of life. PROSPECT seeks to address this important evidence gap and describe the long-term clinical outcomes and disease burden of advancing Parkinson’s disease in patients with motor fluctuations inadequately controlled by their current PD medications.
Additional studies for Parkinson’s and other disorders at RWJ will be listed as they are approved.
