Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease
Public ClinicalTrials.gov record NCT00809302. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm. The study drug will be taken twice a day (BID). The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving. Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period. The entire study will take about 13 weeks. The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.
Study identification
- NCT ID
- NCT00809302
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 9 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2008
- Primary completion
- Jul 31, 2009
- Completion
- Sep 30, 2009
- Last update posted
- Aug 27, 2009
2008 – 2009
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama At Birmingham (052) | Birmingham | Alabama | 35294 | — |
| Mayo Clinic Arizona (060) | Scottsdale | Arizona | 85259 | — |
| The Parkinson's Institute (012) | Sunnyvale | California | 94085 | — |
| Colorado Neurological Institute (052) | Englewood | Colorado | 80113 | — |
| Associated Neurologists, PC (190) | Danbury | Connecticut | 06810 | — |
| Eastern Connecticut Neurology Specialists (215) | Manchester | Connecticut | 06040 | — |
| Institute for Neurodegenerative Disorders (034) | New Haven | Connecticut | 06510 | — |
| Parkinson's Disease & Movement Disorders Center of Boca Raton (196) | Boca Raton | Florida | 33486 | — |
| University of Miami (014) | Miami | Florida | 33136 | — |
| University of South Florida (019) | Tampa | Florida | 33606 | — |
| Southern Illinois University (138) | Springfield | Illinois | 62794 | — |
| University of Kentucky (172) | Lexington | Kentucky | 40536 | — |
| University of Louisville (087) | Louisville | Kentucky | 40205 | — |
| Ochsner Clinic Foundation (207) | New Orleans | Louisiana | 70121 | — |
| LSU Health Science Center Shreveport (132) | Shreveport | Louisiana | 71103 | — |
| Boston University (040) | Boston | Massachusetts | 02118 | — |
| Washington University (027) | St Louis | Missouri | 63110 | — |
| Albany Medical College (037) | Albany | New York | 12208 | — |
| University of Rochester (001) | Rochester | New York | 14618 | — |
| Duke University Medical Center (119) | Durham | North Carolina | 27705 | — |
| University of Cincinnati/Cincinnati Children's Hospital (089) | Cincinnati | Ohio | 45219 | — |
| University of Pennsylvania (018) | Philadelphia | Pennsylvania | 19107 | — |
| Baylor College of Medicine (007) | Houston | Texas | 77030 | — |
| Booth Gardner Parkinson's Care Center (220) | Kirkland | Washington | 98034 | — |
| Medical College of Wisconsin (104) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00809302, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2009 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00809302 live on ClinicalTrials.gov.