Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00479401 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 539
- Enrollment target
NCT00479401: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00479401 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 539 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00479401, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 539 participants
- Enrollment target
Study Summary
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
Primary Outcome
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
Interventions
- DRUG Placebo
- DRUG Pramipexol Extended Release
- DRUG Pramipexol Immediate Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 539 participants |
| Start Date | 2007-05 |
| Phase | Phase 3 |
What the finished NCT00479401 record still lists
NCT00479401 is an interventional study that assigns participants to a tested intervention. The registered 539 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00479401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00479401 about?
NCT00479401 is a clinical study titled "Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients". 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,...
What is the current status of trial NCT00479401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2007-05.
What interventions are being tested in trial NCT00479401?
The interventions under investigation include: Placebo (DRUG), Pramipexol Extended Release (DRUG), Pramipexol Immediate Release (DRUG).
Who is sponsoring clinical trial NCT00479401?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00479401's enrollment target sits among peer trials
539 700th of 2000 higher than 1,301 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04557462 · 540 participants · Phase 3
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
- NCT04956640 · 540 participants · Phase 1
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
- NCT05429892 · 540 participants · NA
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
- NCT05549297 · 540 participants · Phase 3
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia