Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006337
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-10-04
Brief Title:
KW-6002 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:
Adenosine A2A Blockade With KW-6002 in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2002-01
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 KW-6002 on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term treatment with levodopa This drug blocks the action of the neurotransmitter adenosine thought to be involved in producing Parkinsons symptoms
Patients with relatively advanced Stage II to IV Parkinsons disease between 30 and 80 years of age may be eligible for this 7-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 enrolled in the study will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration For the first 1 to 3 days patients will be admitted to the NIH Clinical center to undergo a levodopa dose-finding procedure For this study patients will stop taking Sinemet and instead will have levodopa infused through a vein for up to 8 hoursday During the infusions the drug dose will be increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Symptoms will be monitored frequently to find two infusion rates 1 one that is less than what is needed to relieve symptoms and 2 one that relieves symptoms but may produce dyskinesias This procedure will be repeated at the end of weeks 2 4 and 6 of the study
When the patients optimal dose is determined treatment will begin Patients will take tablets or capsules containing KW-6002 or placebo a look-alike pill with no active ingredient once a day for 2 weeks in addition to their regular Sinemet All participants will receive placebo at least 2 weeks during the study some patients will receive only placebo throughout the entire 7 weeks At the end of weeks 1 3 and 5 patients will be evaluated with a brief physical examination routine blood and urine tests and assessment of any adverse effects
Throughout the study parkinsonian 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 80 years of age may be eligible for this 7-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 enrolled in the study will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration For the first 1 to 3 days patients will be admitted to the NIH Clinical center to undergo a levodopa dose-finding procedure For this study patients will stop taking Sinemet and instead will have levodopa infused through a vein for up to 8 hoursday During the infusions the drug dose will be increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Symptoms will be monitored frequently to find two infusion rates 1 one that is less than what is needed to relieve symptoms and 2 one that relieves symptoms but may produce dyskinesias This procedure will be repeated at the end of weeks 2 4 and 6 of the study
When the patients optimal dose is determined treatment will begin Patients will take tablets or capsules containing KW-6002 or placebo a look-alike pill with no active ingredient once a day for 2 weeks in addition to their regular Sinemet All participants will receive placebo at least 2 weeks during the study some patients will receive only placebo throughout the entire 7 weeks At the end of weeks 1 3 and 5 patients will be evaluated with a brief physical examination routine blood and urine tests and assessment of any adverse effects
Throughout the study parkinsonian 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 adenosine A2a receptor blockade on parkinsonian symptoms and levodopa-associated motor response complications in patients with advanced Parkinsons disease In a controlled 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 |
|---|---|---|---|
| 01-N-0001 | None | None | None |