Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006077
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-08-04
Brief Title:
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2003-07
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 effects of an experimental drug called NS2330 on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term treatment with levodopa This drug prevents the neurotransmitter dopamine from entering nerve cells
Patients between 18 and 75 years old who have moderately advanced Parkinsons disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study Candidates will have a complete medical history and physical examination with a detailed neurological evaluation If needed some patients will undergo a magnetic resonance imaging MRI or computerized tomography CT scan of the brain and a chest X-ray All patients will have blood and urine tests and an electrocardiogram EKG and will take a written test for evaluation of depression
Patients enrolled in the study will if possible stop taking all antiparkinson medications except levodopa Sinemet for one month before the study begins and through its duration For the first 1 to 3 days patients will undergo a levodopa dose-finding procedure For this study patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours During the infusions the drug dose will be increased slowly until either 1 parkinsonism symptoms improve 2 dyskinesias appear 3 unacceptable side effects occur or 4 the maximum study dose is reached
When the patients optimal dose is determined treatment will begin Patients will take three pills containing NS2330 or placebo a look-alike pill with no active ingredient 3 days a week for up to 5 weeks in addition to their regular levodopa medication All participants will receive placebo at some point in the study some patients will receive only placebo throughout the entire 5 weeks
On treatment days patients will have a brief medical examination before receiving the drug and will then be monitored for side effects for about 6 to 8 hours after taking the drug At the beginning of weeks 2 and 5 the levodopa infusions will be repeated at the previously determined optimum rate Throughout the study parkinsonism symptoms dyskinesias and depression will be evaluated Blood and urine samples will be collected each week for standard safety tests and blood will also be drawn periodically to measure NS2330 levels
Patients between 18 and 75 years old who have moderately advanced Parkinsons disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study Candidates will have a complete medical history and physical examination with a detailed neurological evaluation If needed some patients will undergo a magnetic resonance imaging MRI or computerized tomography CT scan of the brain and a chest X-ray All patients will have blood and urine tests and an electrocardiogram EKG and will take a written test for evaluation of depression
Patients enrolled in the study will if possible stop taking all antiparkinson medications except levodopa Sinemet for one month before the study begins and through its duration For the first 1 to 3 days patients will undergo a levodopa dose-finding procedure For this study patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours During the infusions the drug dose will be increased slowly until either 1 parkinsonism symptoms improve 2 dyskinesias appear 3 unacceptable side effects occur or 4 the maximum study dose is reached
When the patients optimal dose is determined treatment will begin Patients will take three pills containing NS2330 or placebo a look-alike pill with no active ingredient 3 days a week for up to 5 weeks in addition to their regular levodopa medication All participants will receive placebo at some point in the study some patients will receive only placebo throughout the entire 5 weeks
On treatment days patients will have a brief medical examination before receiving the drug and will then be monitored for side effects for about 6 to 8 hours after taking the drug At the beginning of weeks 2 and 5 the levodopa infusions will be repeated at the previously determined optimum rate Throughout the study parkinsonism symptoms dyskinesias and depression will be evaluated Blood and urine samples will be collected each week for standard safety tests and blood will also be drawn periodically to measure NS2330 levels
Detailed Description:
The objective of this study is to evaluate the acute effects of a potent inhibitor of dopamine reuptake on the severity of parkinsonian signs and levodopa-associated motor response complications in patients with Parkinsons disease In a controlled proof-of-principle clinical trial the efficacy of NS2330 will be assessed through the use of validated motor function scales Safety will be monitored by means of frequent clinical evaluations and laboratory tests
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 |
|---|---|---|---|
| 00-N-0187 | None | None | None |