NE3107 for Parkinson's Disease

(SUNRISE-PD Trial)

Recruiting at 5 trial locations

Overseen By Clarence Ahlem

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: BioVie Inc.

Must not be taking: Levodopa

Disqualifiers: Major mental, physical illness, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are: * Will bezisterim decrease movement symptoms of Parkinson's disease? * What medical problems do participants have when taking bezisterim? Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease. Participants will * have a physical examination that includes an electrocardiogram * take drug or placebo twice daily for four months * visit a clinical site or receive an at home visit seven times over the course of five months

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken levodopa or similar drugs for Parkinson's symptoms before joining.

Is NE3107 safe for humans?

There is no specific safety data available for NE3107 in the provided research articles. ^{1 2 3 4 5}

How does the drug NE3107 differ from other treatments for Parkinson's disease?

NE3107 is unique because it shows promise in delaying the onset of disabling Parkinsonism, which is different from most current treatments that primarily focus on managing symptoms rather than preventing disease progression. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for people aged 45-80 with early Parkinson's who are close to needing symptom relief but haven't started treatment like levodopa. They must be in good health, agree to birth control, consent voluntarily, and allow DNA analysis from blood samples. Only those diagnosed within the last 18 months can join.

Inclusion Criteria

I am between 45 and 80 years old.

I agree to use birth control during the study.

I have agreed to participate in this study willingly.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take bezisterim or placebo twice daily for four months

16 weeks

7 visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NE3107 (Other)

Trial Overview The study tests NE3107 against a placebo to see if it reduces movement symptoms in Parkinson's patients. Participants will take the drug or placebo twice daily for four months and attend seven visits over five months for physical exams including an ECG.

Participant Groups

Group I: NE3107 Experimental Treatment 1 Intervention

Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.

Group II: Placebo Placebo Group 1 Intervention

Subjects will receive matching placebo capsules for oral administration BID (twice daily).

Who Is Running the Clinical Trial?

BioVie Inc.

Lead Sponsor

Trials

8

Recruited

800+

Findings from Research

In a study involving 22 Parkinson's disease patients, a single dose of the NR2B antagonist MK-0657 (7 mg) did not significantly reduce levodopa-induced dyskinesias or improve motor symptoms, indicating it may not be an effective treatment for these issues.

Despite achieving the target plasma concentration of the drug, MK-0657 showed no meaningful impact on dyskinesia or motor function as measured by established scales, suggesting that further research is needed to explore effective treatments for levodopa-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Herring, WJ., Assaid, C., Budd, K., et al.[2018]

In a study involving 16 patients with moderate Parkinson's disease, the NR2B-selective NMDA receptor antagonist MK-0657 did not show significant improvement in motor function compared to placebo, despite achieving the target plasma concentration.

While MK-0657 was generally well tolerated, it did lead to increases in blood pressure, indicating potential safety concerns that may limit its use in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Addy, C., Assaid, C., Hreniuk, D., et al.[2013]

In a study involving 65 Parkinson's disease patients, the oral formulation NC001 significantly reduced falls and freezing of gait (FOG) compared to placebo, indicating its potential efficacy in managing these challenging symptoms.

NC001 was found to be safe and well-tolerated, with a notable improvement in ambulation as measured by the Unified Dyskinesia Rating Scale, suggesting that it effectively stimulates nicotinic receptors to alleviate certain motor symptoms in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine Bitartrate Reduces Falls and Freezing of Gait in Parkinson Disease: A Reanalysis. Lieberman, A., Lockhart, TE., Olson, MC., et al.[2020]

In a study involving eight parkinsonian monkeys, co-administration of the NMDA receptor antagonist CI-1041 with L-dopa significantly reduced the development of L-dopa-induced dyskinesias (LID), with only one monkey showing mild symptoms compared to all four in the L-dopa alone group.

The effectiveness of L-dopa in alleviating Parkinson's symptoms remained similar in both treatment groups, indicating that CI-1041 can potentially manage LID without compromising the therapeutic benefits of L-dopa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. Hadj Tahar, A., Grégoire, L., Darré, A., et al.[2014]

In a phase 2 study involving 71 patients with Parkinson's disease and levodopa-induced dyskinesia, the nicotinic acetylcholine receptor α7 agonist AQW051 did not show significant improvements in reducing dyskinesia or overall Parkinson's symptoms after 28 days of treatment.

AQW051 was well tolerated by participants, with common side effects including dyskinesia, fatigue, nausea, and falls, indicating that while it may not be effective, it does not pose major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Trenkwalder, C., Berg, D., Rascol, O., et al.[2019]

A new drug has demonstrated potential in delaying the onset of Parkinsonism, which is a significant advancement for patients at risk of developing this condition.

The findings suggest that this drug could improve the quality of life for individuals by postponing the debilitating symptoms associated with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

In a study involving 80 participants, those treated with acupuncture combined with madopar showed a 92% effective rate in alleviating motor disorders due to Parkinson's disease, significantly higher than the control group that received madopar alone.

The results suggest that acupuncture not only enhances the effectiveness of madopar but may also allow for a reduced dosage of the medication needed for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifty cases of Parkinson's disease treated by acupuncture combined with madopar. Ren, XM.[2019]

Despite extensive research and numerous clinical trials since the 1980s, no treatment has been proven to effectively halt or slow the progression of Parkinson's disease, highlighting the challenges in translating laboratory findings into effective therapies.

Various classes of compounds, including monoamine oxidase-B inhibitors and dopaminergic drugs, have been tested, but the search for effective neuroprotective treatments continues, with emerging strategies like gene therapy showing potential for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection against Parkinson's disease progression: clinical experience. LeWitt, PA., Taylor, DC.[2021]

Deep brain stimulation (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Long-term levodopa therapy for Parkinson's disease can lead to late motor complications due to its rapid action and competition with amino acids, which may be exacerbated by disease progression.

Cabergoline, a long-acting dopamine D2 receptor agonist, shows promise as an alternative to levodopa, with initial studies indicating comparable efficacy and potential to reduce late motor complications through steady receptor stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic and pharmacokinetic features of cabergoline. Rationale for use in Parkinson's disease. Fariello, RG.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotine Bitartrate Reduces Falls and Freezing of Gait in Parkinson Disease: A Reanalysis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

7. China pubmed.ncbi.nlm.nih.gov

Fifty cases of Parkinson's disease treated by acupuncture combined with madopar. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Protection against Parkinson's disease progression: clinical experience. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacodynamic and pharmacokinetic features of cabergoline. Rationale for use in Parkinson's disease. [2018]