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Terminated Phase 2 Interventional

Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease

ClinicalTrials.gov ID: NCT00809302

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 7:46 PM EDT

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
Lead sponsor
Neurogen Corporation
Industry
Enrollment
9 participants

Conditions and interventions

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
Dec 2008 (Type not available)
Primary completion
Aug 2009 (Estimated)
Completion
Oct 2009 (Estimated)
Last update posted
Aug 28, 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 28, 2009 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00809302 live on ClinicalTrials.gov.

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