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This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo.
The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given.
The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | AP-472 100 mg per day |
|
| High Dose | Experimental | AP-472 300 mg per day |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-472 | Drug | Oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours) | Week 12 | |
| Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score |
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Key Inclusion Criteria:
Participants must meet all of the following criteria to take part in the study:
Key Exclusion Criteria:
Participants cannot take part in the study if any of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie Blobaum, Ph.D. | Contact | 615-427-1935 | annie@appellopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Not yet recruiting | Little Rock | Arkansas | 72205-5551 | United States | |
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| Other |
Oral tablet |
|
For MDS-UPDRS Part II (Motor Experiences of Daily Living, M-EDL) there are 13 items each scored from 0 to 4. The total score range is from 0-52. A higher score indicates worse motor impact on daily activities; lower scores are better.
| Week 12 |
| Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index | For the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index the score is calculated by averaging the 8 domain scores and converting them to a 0-100 scale. A higher score indicates worse health-related quality of life; lower scores are better. | Week 12 |
| Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state | The MDS-UPDRS Part III includes 33 items, each scored from 0 to 4. The total score range is from 0-132. A higher score indicates worse motor impairment; lower scores are better. | Week 12 |
| Change from baseline in Epworth Sleepiness Scale (ESS) total score | The ESS consists of 8 items, each scored from 0 to 3. The total score range is from 0-24. Higher scores indicate greater daytime sleepiness; lower scores are better. | Week 12 |
| Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS |
| Not yet recruiting |
| Los Alamitos |
| California |
| 90720-3108 |
| United States |
| Keck Medicine of USC - USC Healthcare Center 2 | Not yet recruiting | Los Angeles | California | 90033-5310 | United States |
| North County Neurology Associates | Not yet recruiting | Oceanside | California | 92056-4454 | United States |
| Parkinson's Research Centers of America | Not yet recruiting | Palo Alto | California | 94301 | United States |
| Rocky Mountain Clinical Research - CenExel - PPDS | Not yet recruiting | Englewood | Colorado | 80113-2776 | United States |
| University of Miami | Not yet recruiting | Miami | Florida | 33136-1051 | United States |
| Neurology One | Not yet recruiting | Orlando | Florida | 32825 | United States |
| USF Parkinson's Disease and Movement Disorders Center | Not yet recruiting | Tampa | Florida | 33613-4808 | United States |
| Augusta University Medical Center | Not yet recruiting | Augusta | Georgia | 30912-0020 | United States |
| The University of Kansas (KU) | Not yet recruiting | Kansas City | Kansas | 66103-2078 | United States |
| Kentucky Neuroscience Institute | Not yet recruiting | Lexington | Kentucky | 40536-0001 | United States |
| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215-5400 | United States |
| University of Michigan Health System (UMHS) | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Quest Research Institute - Alcanza - PPDS | Recruiting | Farmington Hills | Michigan | 48334-2973 | United States |
| University of New Mexico Health Sciences Center | Not yet recruiting | Albuquerque | New Mexico | 87131-0001 | United States |
| Mount Sinai School of Medicine | Not yet recruiting | New York | New York | 10029-6501 | United States |
| Joan and Sanford I. Weill Department of Medicine | Not yet recruiting | New York | New York | 10065 | United States |
| Duke Neurological Disorders Clinic | Not yet recruiting | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195-0001 | United States |
| The Ohio State University Wexner Medical Center | Not yet recruiting | Columbus | Ohio | 43202-4500 | United States |
| Movement Disorder Clinic of Oklahoma PLLC | Not yet recruiting | Tulsa | Oklahoma | 74136-7027 | United States |
| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
| Central Texas Neurology Consultants | Recruiting | Round Rock | Texas | 78681-3578 | United States |
| EvergreenHealth | Not yet recruiting | Kirkland | Washington | 98034-3013 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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