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NCT00402233 · ClinicalTrials.gov registry record · Phase 4

A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients

A Phase 4 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 4
Development phase
312
Enrollment target

NCT00402233: Completed Phase 4 study, sponsored by Boehringer Ingelheim.

NCT00402233 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 312 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00402233, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 4
Development phase
312 participants
Enrollment target

Study Summary

Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

Primary Outcome

Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)

Interventions

  • DRUG Placebo
  • DRUG Pramipexole

Trial Details

FieldValue
Enrollment Target 312 participants
Start Date 2006-11
Phase Phase 4
Boehringer Ingelheim

515 total trials

What the finished NCT00402233 record still lists

NCT00402233 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00402233 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00402233 about?

NCT00402233 is a clinical study titled "A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients". Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among ...

What is the current status of trial NCT00402233?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 312 participants. The study started on 2006-11.

What interventions are being tested in trial NCT00402233?

The interventions under investigation include: Placebo (DRUG), Pramipexole (DRUG).

Who is sponsoring clinical trial NCT00402233?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00402233's enrollment target sits among peer trials

312 262nd of 2000 higher than 1,738 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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

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Source: ClinicalTrials.gov NCT00402233, the US trial registry maintained by the National Library of Medicine. NCT00402233 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.