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NCT00089622 · ClinicalTrials.gov registry record · Phase 2

Lisuride Patch to Treat Parkinson's Disease

A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00089622: Completed Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00089622 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00089622, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

This study will evaluate the effectiveness of a skin patch formulation of the dopamine agonist Lisuride in controlling parkinsonian symptoms and dyskinesias (involuntary movements) caused by levodopa. Lisuride is currently available in tablet form; this study will test whether a patch formulation that provides continuous stimulation of the dopamine receptors will better control disease symptoms. Patients between 40 and 80 years old with Parkinson's disease and dyskinesias may be eligible for this 4-month study. Participants undergo the following procedures: Screening and baseline evaluation: Participants are evaluated with a medical history, physical examination, neurologic evaluation, blood tests, urinalysis, and electrocardiogram. A chest X-ray and MRI or CT scan of the brain are done, if needed. If possible, patients stop taking all antiparkinsonian medications except levodopa (Sinemet) for 1 month (2 months for Selegiline) before the study begins and throughout its duration. Dose-finding phase: Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusions, the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) Active study phase: Patients are randomly assigned to one of two treatment groups. One group receives a placebo (a patch with no active drug) and a patch that contains Lisuride; the other group receives placebo throughout the entire study. Patients are instructed on how to apply the patches. During the first 2 weeks of this study phase, the number of patches containing active drug is gradually increased until the individual's optimum dose is reached. Patches are chang

Interventions

  • DRUG Intravenous Levodopa
  • DRUG Lisuride Transdermal System

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2004-08-04
Est. Completion 2007-03-31
Phase Phase 2

What the finished NCT00089622 record still lists

NCT00089622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

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

NCT00089622 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00089622 about?

NCT00089622 is a clinical study titled "Lisuride Patch to Treat Parkinson's Disease". This study will evaluate the effectiveness of a skin patch formulation of the dopamine agonist Lisuride in controlling parkinsonian symptoms and dyskinesias (involuntary movements) caused by levodopa. Lisuride is currently available in tablet form; this study will test whether a patch formulation th...

What is the current status of trial NCT00089622?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-08-04. Estimated completion is 2007-03-31.

What interventions are being tested in trial NCT00089622?

The interventions under investigation include: Intravenous Levodopa (DRUG), Lisuride Transdermal System (DRUG).

Who is sponsoring clinical trial NCT00089622?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00089622's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00089622, the US trial registry maintained by the National Library of Medicine. NCT00089622 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.