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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-08-04 |
| Est. Completion | 2007-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089622
The ClinicalTrials.gov registry entry for NCT00089622 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intravenous Levodopa is the first listed.
NCT00089622 reports 0 study locations.
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.
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