Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004576
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-02-17
Brief Title:
Study of LY300164 for the Treatment of Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
AMPA Receptor Blockade With LY300164 in the Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2000-02
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 test the effectiveness of an experimental drug called LY300164 on improving Parkinsons disease symptoms such as movement impairments and tremor as well as involuntary movements produced by long-term treatment with levodopa
Patients with relatively advanced Stage II to IV Parkinsons disease between 30 and 75 years of age may be eligible for this 8-week study Participants will have a complete medical history and physical examination including blood tests and an electrocardiogram and possibly brain magnetic resonance imaging MRI CT scan and chest X-ray
Patients will stop taking all anti-parkinsonism medications except levodopa Sinemet and the experimental drug during the study For the first 1 to 3 days patients will be in the hospital for a levodopa dose-finding procedure For this study levodopa is infused through a vein for up to 8 hours with symptoms monitored frequently to determine the doses that will produce two results 1 the dose that is less than what is needed to relieve symptoms and 2 the dose that relieves symptoms but may produce dyskinesias
When these dose rates are determined patients will begin treatment in one of two groups One will take LY300164 3 times a day along with levodopa for 3 weeks The second group will take placebo tablets a look-alike tablet with no active ingredient and levodopa on the same schedule as the LY300164 group A brief medical examination and routine blood and urine tests will be done weekly The drug dose will be increased every 3 to 4 days until significant side effects occur or the maximal dose is reached Patients will be closely monitored for 4 hours after every increase At the end of the 3 weeks or when the maximal dose is reached patients will be readmitted to the hospital for 2 to 3 days for a second levodopa dose-finding study while continuing on LY300164 or placebo After this test patients will resume taking levodopa and the experimental drug or placebo as before for another 2 weeks
At the end of the 2-weeks the entire procedure will be repeated in both groups but the treatments will be switched-that is the patients who were taking LY300164 will now take placebo and the patients who took placebo will now take the drug At the end of the second 3 weeks the levodopa infusion procedure will be repeated once more
Throughout the study parkinsonism symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels
Patients with relatively advanced Stage II to IV Parkinsons disease between 30 and 75 years of age may be eligible for this 8-week study Participants will have a complete medical history and physical examination including blood tests and an electrocardiogram and possibly brain magnetic resonance imaging MRI CT scan and chest X-ray
Patients will stop taking all anti-parkinsonism medications except levodopa Sinemet and the experimental drug during the study For the first 1 to 3 days patients will be in the hospital for a levodopa dose-finding procedure For this study levodopa is infused through a vein for up to 8 hours with symptoms monitored frequently to determine the doses that will produce two results 1 the dose that is less than what is needed to relieve symptoms and 2 the dose that relieves symptoms but may produce dyskinesias
When these dose rates are determined patients will begin treatment in one of two groups One will take LY300164 3 times a day along with levodopa for 3 weeks The second group will take placebo tablets a look-alike tablet with no active ingredient and levodopa on the same schedule as the LY300164 group A brief medical examination and routine blood and urine tests will be done weekly The drug dose will be increased every 3 to 4 days until significant side effects occur or the maximal dose is reached Patients will be closely monitored for 4 hours after every increase At the end of the 3 weeks or when the maximal dose is reached patients will be readmitted to the hospital for 2 to 3 days for a second levodopa dose-finding study while continuing on LY300164 or placebo After this test patients will resume taking levodopa and the experimental drug or placebo as before for another 2 weeks
At the end of the 2-weeks the entire procedure will be repeated in both groups but the treatments will be switched-that is the patients who were taking LY300164 will now take placebo and the patients who took placebo will now take the drug At the end of the second 3 weeks the levodopa infusion procedure will be repeated once more
Throughout the study parkinsonism symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels
Detailed Description:
The objective of this study is to evaluate the acute effects of alpha-amino-3-hydroxy-5-methyl-4-isoxazole proprionic acid AMPA receptor blockade 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 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
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-0084 | None | None | None |