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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NE3107 | Experimental | Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules. |
|
| Placebo | Placebo Comparator | Subjects will receive matching placebo capsules for oral administration BID (twice daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NE3107 | Drug | NE3107 20 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the MDS-UPDRS Part III | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is comprised of 4 parts: This study will use MDS-UPDRS Parts I, II, and III. The primary efficacy endpoint is change in the modified MDS-UPDRS Part III score. Scores (0-4: Normal to severe impact) are derived from clinician and subject input to allow the assessment of symptomatic worsening, stability, or improvement. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MDS-UPDRS Part I and II | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is comprised of 4 parts: This study will use MDS-UPDRS Parts I, II, and III. Secondary efficacy endpoints in the study will include change in the modified MDS-UPDRS Part I and II scores. Scores (0-4: Normal to severe impact) are derived from clinician and subject input to allow the assessment of symptomatic worsening, stability, or improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States | ||
| Dent Neurologic |
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| Label | URL |
|---|---|
| www.SunrisePD.com | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Drug |
Placebo BID |
|
| 12 weeks |
| Percent of subjects with improvement in Clinical Global Impression | Percent of subjects with any improvement as measured by Clinical Global Impression. | 12 weeks |
| Amherst |
| New York |
| 14226 |
| United States |
| Science 37 (Nationwide Site) | Morrisville | North Carolina | 27560 | United States |
| NeuroScience Research Center, LLC | Canton | Ohio | 44718 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |