Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013624
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-03-24
Brief Title:
Riluzole 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:
Effect of Antiglutamatergic Treatment in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2005-03
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 the drug riluzole on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term treatment with levodopa Riluzole blocks the action of the chemical messenger glutamate thought to be involved in producing Parkinsons symptoms The drug is currently approved to treat amyotrophic lateral sclerosis another neurologic condition
Patients with relatively advanced Parkinsons disease between 20 and 80 years of age may be eligible for this 4-week study Participants will have a complete medical history and physical examination and a detailed neurological evaluation The evaluations will include blood tests and an electrocardiogram and possibly brain magnetic resonance imaging MRI CT scan and chest X-ray
Participants 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 their oral Sinemet and instead will have levodopa infused through a vein for up to 8 hoursday During the infusions the levodopa 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 suboptimal rate and 2 one that relieves symptoms but may produce dyskinesias optimal rate
When the dose-finding phase is completed treatment will begin Patients will take riluzole or placebo a look-a-like pill with no active ingredient twice a day along with their regular Sinemet for 3 weeks All participants will receive placebo at some time during the study and some patients will receive only placebo throughout the entire 4 weeks At the end of each week patients will be readmitted to the hospital and receive the previous weeks dose of riluzole or placebo in combination with a levodopa infusion at the rate determined in the dose-finding phase of the study The procedure for the infusion will be the same as that for the dose-finding phase The dose of riluzole will be increased until the optimum dose has been achieved or until side effects occur at which time the dose will be lowered or the drug stopped
Throughout the study parkinsonian symptoms and dyskinesias will be evaluated using standardized rating scales and blood samples will be drawn periodically to measure drug levels
Patients with relatively advanced Parkinsons disease between 20 and 80 years of age may be eligible for this 4-week study Participants will have a complete medical history and physical examination and a detailed neurological evaluation The evaluations will include blood tests and an electrocardiogram and possibly brain magnetic resonance imaging MRI CT scan and chest X-ray
Participants 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 their oral Sinemet and instead will have levodopa infused through a vein for up to 8 hoursday During the infusions the levodopa 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 suboptimal rate and 2 one that relieves symptoms but may produce dyskinesias optimal rate
When the dose-finding phase is completed treatment will begin Patients will take riluzole or placebo a look-a-like pill with no active ingredient twice a day along with their regular Sinemet for 3 weeks All participants will receive placebo at some time during the study and some patients will receive only placebo throughout the entire 4 weeks At the end of each week patients will be readmitted to the hospital and receive the previous weeks dose of riluzole or placebo in combination with a levodopa infusion at the rate determined in the dose-finding phase of the study The procedure for the infusion will be the same as that for the dose-finding phase The dose of riluzole will be increased until the optimum dose has been achieved or until side effects occur at which time the dose will be lowered or the drug stopped
Throughout the study parkinsonian symptoms and dyskinesias will be evaluated using standardized rating scales 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 a nonselective inhibitor of glutamate mediated synaptic transmission on the severity of parkinsonian signs and levodopa-associated motor response complications in patients with moderately advanced Parkinsons disease In a controlled proof-of-principle clinical trial the efficacy of the glutamate release inhibitor riluzole 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-0118 | None | None | None |