Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089622
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-08-06
Brief Title:
Lisuride Patch to Treat Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Transcutaneous Lisuride Therapy of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2007-03-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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 individuals optimum dose is reached Patches are changed about every 2 days During this time intake of other antiparkinsonian medications is tapered down and patients are evaluated frequently For the next 3 months patients wear the patches continuously at the optimum dose The patches are changed every 2 days or once a week depending on the individual patients need Two levodopa infusion studies are done in the active study phase as they were in the dose-finding phase - at the beginning of the dose escalation phase and again at the end of the dose maintenance phase In addition patients are tested for their ability to perform different motor tasks
Sleep studies Because oral Lisuride can cause excessive sleepiness some patients are asked to participate in a sleep study to evaluate sleep patterns during the night and daytime sleepiness The subjects brain muscles and breathing are continuously monitored during sleep Also an electroencephalogram EEG is done to record brain waves while the subject lies quietly breathes deeply watches flashes of light sleeps or performs a task
Safety checks Patients are monitored closely for safety with a history of side effects blood tests and ECG each time a new supply of study drug is dispensed
Follow-up 2 weeks after completing the active phase of the study patients are contacted by phone for a follow-up evaluation
Patients between 40 and 80 years old with Parkinsons 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 individuals optimum dose is reached Patches are changed about every 2 days During this time intake of other antiparkinsonian medications is tapered down and patients are evaluated frequently For the next 3 months patients wear the patches continuously at the optimum dose The patches are changed every 2 days or once a week depending on the individual patients need Two levodopa infusion studies are done in the active study phase as they were in the dose-finding phase - at the beginning of the dose escalation phase and again at the end of the dose maintenance phase In addition patients are tested for their ability to perform different motor tasks
Sleep studies Because oral Lisuride can cause excessive sleepiness some patients are asked to participate in a sleep study to evaluate sleep patterns during the night and daytime sleepiness The subjects brain muscles and breathing are continuously monitored during sleep Also an electroencephalogram EEG is done to record brain waves while the subject lies quietly breathes deeply watches flashes of light sleeps or performs a task
Safety checks Patients are monitored closely for safety with a history of side effects blood tests and ECG each time a new supply of study drug is dispensed
Follow-up 2 weeks after completing the active phase of the study patients are contacted by phone for a follow-up evaluation
Detailed Description:
Introduction Parkinsons disease PD is a progressive degenerative disease of unknown etiology Treatment is symptomatic and the most successful approach has been to replace the missing dopamine through administration of its precursor levodopa As the disease progresses the usefulness of this approach gradually diminishes and motor complications become a source of significant disability Although a number of pharmacological strategies have attempted to improve this situation none has yet proven fully satisfactory A novel transcutaneous formulation of the dopamine agonist lisuride will be used to test the ability of this approach to reduce levodopa-induced motor response complications
Objective The objective of this study is to evaluate the risks and benefits of continuous dopaminomimetic replacement therapy in patients with advanced Parkinsons disease
Study population Approximately 22 moderately advanced parkinsonian patients will be enrolled into a randomized placebo-controlled double-blind proof-of-principle study lasting approximately 16 weeks Lisuride efficacy will be assessed through the use of validated motor function scales Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Anticipated Risks and Benefits The potential risks associated with this study amount to only a minor increase over minimal risk and are primarily associated with adverse reactions to the medications involved Lisuride has been approved for use in Europe for more than 20 years and has a wide margin of safety Patients receiving drug could benefit from improvement of their clinical condition those on placebo will also receive proper medical care that may lead to a better quality of life
Outcome Estimate and Potential Meaning for the Field This study should further the understanding of mechanisms contributing to motor disability in patients with PD and thus lead to the development of improved therapeutic interventions for this disorder and for associated motor response complications
Objective The objective of this study is to evaluate the risks and benefits of continuous dopaminomimetic replacement therapy in patients with advanced Parkinsons disease
Study population Approximately 22 moderately advanced parkinsonian patients will be enrolled into a randomized placebo-controlled double-blind proof-of-principle study lasting approximately 16 weeks Lisuride efficacy will be assessed through the use of validated motor function scales Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Anticipated Risks and Benefits The potential risks associated with this study amount to only a minor increase over minimal risk and are primarily associated with adverse reactions to the medications involved Lisuride has been approved for use in Europe for more than 20 years and has a wide margin of safety Patients receiving drug could benefit from improvement of their clinical condition those on placebo will also receive proper medical care that may lead to a better quality of life
Outcome Estimate and Potential Meaning for the Field This study should further the understanding of mechanisms contributing to motor disability in patients with PD and thus lead to the development of improved therapeutic interventions for this disorder and for associated motor response complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0258 | None | None | None |