Parkinsons Disease (PD)Phase 2SUNRISE-PDNCT06757010
A Study of NE3107 in Early Parkinson's
A Phase 2 study testing NE3107 in people with Parkinsons Disease (PD), run by BioVie Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinsons Disease (PD)
- What is being tested?
- NE3107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Mar 2025to 31 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years to 80 years of age
- diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
- nearing the need for symptomatic therapy
- agree to use birth control measures
- provide voluntary consent
- willing to allow blood collection for DNA methylation analysis
- pass all screening tests and procedures
Who cannot join
- has taken levodopa or another similar drug for the motor symptoms of PD
- a known or strongly suspected familial cause for PD diagnosis
- major mental health or physical illness
- medical history of major mental or physical illness
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dent Neurologic
Amherst, New York, 14226
NeuroScience Research Center, LLC
Canton, Ohio, 44718
Quest Research Institute
Farmington Hills, Michigan, 48334
Science 37 (Nationwide Site)
Morrisville, North Carolina, 27560
About this study
Official title: A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
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?
Read more
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
- Conditions
- Parkinsons Disease (PD)
- Being tested
- NE3107, Placebo
- Keywords
- Treatment naïve Parkinson's, Early Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NE3107Drug
Also called bezisterim
NE3107 20 mg BID
PlaceboDrug
Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| NE3107 | Experimental | Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules. Receives: Drug: NE3107 |
| Placebo | Placebo comparator | Subjects will receive matching placebo capsules for oral administration BID (twice daily). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte Lymphocyte Ratio (MLR)
A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)
Measured: 12 Weeks
Secondary outcomes (14)
Change in Systemic Inflammation Response Index (SIRI)
A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing.
Measured: 12 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
Measured: 12 weeks
Change in Systemic Immune-Inflammation Index (SII)
A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
Measured: 12 weeks
Change in Platelet-to-Lymphocyte Ratio (PLR)
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
Measured: 12 weeks
Change in Aggregate Index of Systemic Inflammation (AISI)
A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
Measured: 12 weeks
Change in the Composite Benefit Score (CBS)
Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments. Lower scores indicate improvement in Parkinson's disease symptoms.
Measured: 12 weeks
Change in MDS-UPDRS modified Part III
Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination. The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability. Higher scores indicate worse motor impairment.
Measured: 12 weeks
Change in MDS-UPDRS Part II scores
Change from baseline in MDS-UPDRS Part II score. MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement.
Measured: 12 weeks
Change in MDS-UPDRS Part I scores
Change from baseline in MDS-UPDRS Part I score. MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement.
Measured: 12 weeks
Change in MDS-UPDRS combined scores
Change from baseline in the combined MDS-UPDRS score (Parts I + II + III). The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement.
Measured: 12 weeks
Change in PDQ-39 score
Change from baseline in PDQ-39 total score. The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease. Higher scores indicate worse quality of life and negative changes indicate improvement.
Measured: 12 weeks
Clinician's General Impression of Improvement (CGI-I)
Clinician's Global Impression of Improvement (CGI-I) score. The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
Measured: 12 weeks
Clinician's General Impression of Severity (CGI-S)
Change from baseline in Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater severity and negative changes indicate improvement.
Measured: 12 weeks
Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)
Change from baseline in modified PARCOMS-Motor score. PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments. The score was modified to adjust for missing MDS-UPDRS Part III data. Higher scores indicate greater motor impairment and negative changes indicate improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start26 Mar 2025
- Primary completion1 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVie Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757010
- Sponsor's protocol ID
- NE3107-PD-202
- Acronym
- SUNRISE-PD
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06757010
- Acronym / sponsor ID
- SUNRISE-PD / NE3107-PD-202
- Conditions
- Parkinsons Disease (PD)
- Keywords
- Treatment naïve Parkinson's, Early Parkinson's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- BioVie Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NE3107 | Experimental | Drug: NE3107Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive matching placebo capsules for oral administration BID (twice daily). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 45 years to 80 years of age
- diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
- nearing the need for symptomatic therapy
- agree to use birth control measures
- provide voluntary consent
Key exclusion criteria (4 listed)
- has taken levodopa or another similar drug for the motor symptoms of PD
- a known or strongly suspected familial cause for PD diagnosis
- major mental health or physical illness
- medical history of major mental or physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NE3107Also: bezisterimNE3107 20 mg BID | Drug | NE3107 |
| PlaceboPlacebo BID | Drug | Placebo |
Primary outcome
Monocyte Lymphocyte Ratio (MLR)
Time frame: 12 Weeks
A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)
14 secondary outcomes
Change in Systemic Inflammation Response Index (SIRI)
Time frame: 12 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: 12 weeks
Change in Systemic Immune-Inflammation Index (SII)
Time frame: 12 weeks
Change in Platelet-to-Lymphocyte Ratio (PLR)
Time frame: 12 weeks
Change in Aggregate Index of Systemic Inflammation (AISI)
Time frame: 12 weeks
Change in the Composite Benefit Score (CBS)
Time frame: 12 weeks
Change in MDS-UPDRS modified Part III
Time frame: 12 weeks
Change in MDS-UPDRS Part II scores
Time frame: 12 weeks
Change in MDS-UPDRS Part I scores
Time frame: 12 weeks
Change in MDS-UPDRS combined scores
Time frame: 12 weeks
Change in PDQ-39 score
Time frame: 12 weeks
Clinician's General Impression of Improvement (CGI-I)
Time frame: 12 weeks
Clinician's General Impression of Severity (CGI-S)
Time frame: 12 weeks
Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- www.SunrisePD.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NE3107 in people with Parkinsons Disease (PD), run by BioVie Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte Lymphocyte Ratio (MLR) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.