NEU-411 for Parkinson's Disease
(NEULARK Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byFatta B Nahab, MD, FAAN FANA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Neuron23 Inc.
Disqualifiers: Secondary parkinsonian syndromes, uncontrolled diabetes, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
Participants will:
• Take NEU-411 or placebo every day for 52 weeks
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for NEU-411 or similar treatments in humans?
The studies reviewed do not mention NEU-411 specifically, but they do discuss similar treatments for Parkinson's disease. For example, MK-0657, a similar type of treatment, was generally well tolerated but caused increases in blood pressure. This suggests that while these treatments may be safe for some, they could have side effects like changes in blood pressure.
12345Eligibility Criteria
This trial is for men and women aged 50-80 with early Parkinson's Disease, who have a certain genetic profile indicating high activity in the LRRK2 pathway. They must be diagnosed with PD and have a disease severity score (mH&Y) of 1 to 2.5.Inclusion Criteria
I am between 50 and 80 years old.
My Parkinson's is linked to the LRRK2 gene according to a specific test.
My Parkinson's disease is in the early to mid-stage.
+1 more
Exclusion Criteria
I don't have any major health issues apart from my current condition.
My condition is a type of parkinsonism that's not typical Parkinson's disease.
My diabetes is not under control, with HbA1c over 8%.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive NEU-411 or placebo daily for 52 weeks
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
1 visit (in-person)
Participant Groups
The study tests NEU-411 against a placebo over the course of one year to see if it's effective and safe for treating early-stage Parkinson's Disease in patients with specific genetic markers.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NEU-411Experimental Treatment1 Intervention
Orally-administered NEU-411
Group II: PlaceboPlacebo Group1 Intervention
Orally-administered matching placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Quest Research InstituteFarmington Hills, MI
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, FL
Neurology OneOrlando, FL
Struthers Parkinson CenterGolden Valley, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Neuron23 Inc.Lead Sponsor
References
Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. [2018]This prospective, open-label extension (SP702; NCT00594165) of a 6-month double-blind, randomized study investigated the long-term safety and tolerability of rotigotine transdermal system in early Parkinson's disease (PD).
A Phase Ib Randomized Controlled Study to Evaluate the Effectiveness of a Single-Dose of the NR2B Selective N-Methyl-D-Aspartate Antagonist MK-0657 on Levodopa-Induced Dyskinesias and Motor Symptoms in Patients With Parkinson Disease. [2018]Blockade of N-methyl-D-aspartate receptors containing the NR2B subunit has been shown to be therapeutic in animal models of Parkinson disease (PD). However, findings with investigational NR2B receptor antagonists in PD patients have been mixed. The objective of this study was to evaluate the effects of the NR2B selective N-methyl-D-aspartate receptor antagonist MK-0657 on levodopa-induced dyskinesias and motor symptoms in PD patients.
Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not result in clinically meaningful improvement in motor function in patients with moderate Parkinson's disease. [2013]The glutamatergic system is thought to contribute to the motor disturbances observed in Parkinson's disease. Blockade of glutamatergic activity by a selective antagonist of the NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor is associated with improvement in motor symptoms in a preclinical model of Parkinson's disease. A randomized, double-blind, double-dummy, placebo-controlled, 3-period crossover study was conducted in patients with moderate Parkinson's disease to evaluate the pharmacologic activity of MK-0657, an NR2B-selective NMDA receptor antagonist. Patients (n=16) received single oral doses of MK-0657 7 mg, carbidopa/levodopa 25/250 mg (LD) as a positive control, and placebo, after which motor function was serially evaluated by means of the Unified Parkinson's Disease Rating Scale-Motor Examination (UPDRS-ME). LD administration resulted in significant improvement in the UPDRS-ME relative to placebo (P=.025), confirming the sensitivity of the test paradigm; however, the UPDRS-ME change following MK-0657 administration showed no improvement compared with placebo (P=.110) despite exceeding the target MK-0657 plasma concentration of 400 nM. Although the administration of MK-0657 was generally well tolerated, it was associated with increases in systolic and diastolic blood pressure relative to placebo. The results of this study do not support ongoing clinical development of MK-0657 as a novel monotherapy for Parkinson's disease.
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. [2018]There is an unmet medical need for additional treatment options for Parkinson's disease. This was a Phase I, double-blind clinical trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of the novel dopamine D1 receptor partial agonist, PF-06669571, in subjects with idiopathic Parkinson's disease on a stable dose of L-DOPA.
Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease. [2012]This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (> or = 30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P or = 10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.