Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
Public ClinicalTrials.gov record NCT00479401. 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 Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole. In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity
Study identification
- NCT ID
- NCT00479401
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 539 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
- May 2007 (Type not available)
- Primary completion
- Nov 2008 (Actual)
- Completion
- Not listed
- Last update posted
- Jul 17, 2014
Started 2007
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 248.524.01018 Boehringer Ingelheim Investigational Site | Gilbert | Arizona | — | — |
| 248.524.01004 Boehringer Ingelheim Investigational Site | Sun City | Arizona | — | — |
| 248.524.01016 Boehringer Ingelheim Investigational Site | La Jolla | California | — | — |
| 248.524.01013 Boehringer Ingelheim Investigational Site | Oxnard | California | — | — |
| 248.524.01008 Boehringer Ingelheim Investigational Site | Danbury | Connecticut | — | — |
| 248.524.01010 Boehringer Ingelheim Investigational Site | Boca Raton | Florida | — | — |
| 248.524.01014 Boehringer Ingelheim Investigational Site | Augusta | Georgia | — | — |
| 248.524.01012 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 248.524.01001 Boehringer Ingelheim Investigational Site | Kansas City | Kansas | — | — |
| 248.524.01007 Boehringer Ingelheim Investigational Site | Elkridge | Maryland | — | — |
| 248.524.01015 Boehringer Ingelheim Investigational Site | Southfield | Michigan | — | — |
| 248.524.01017 Boehringer Ingelheim Investigational Site | Hattiesburg | Mississippi | — | — |
| 248.524.01005 Boehringer Ingelheim Investigational Site | Commack | New York | — | — |
| 248.524.01002 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 248.524.01003 Boehringer Ingelheim Investigational Site | Midvale | Utah | — | — |
| 248.524.01009 Boehringer Ingelheim Investigational Site | Burlington | Vermont | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00479401, 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 Jul 17, 2014 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00479401 live on ClinicalTrials.gov.