Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040209
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-06-21
Brief Title:
JP-1730 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:
Alpha-2 Adrenergic Antagonist Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2005-07
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 JP-1730 on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term treatment with levodopa JP-1730 affects chemical messengers believed to affect Parkinsons disease symptoms
Patients between 30 and 80 years of age with relatively advanced Parkinsons disease may be eligible for this 3-phase study
Phase 1 - Baseline evaluation
Participants will be evaluated with a medical history physical examination detailed neurologic evaluation routine blood tests urinalysis and an electrocardiogram They will also have a 24-hour holter monitor heart monitoring and cardiology consultation A chest X-ray and MRI or CT scan of the brain will be done if needed Patients will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration If necessary patients may use short-acting dopamine agonists such as Mirapex and Requip
Phase 2 - Dose Finding Phase
For 2 to 3 days patients will be admitted to the NIH Clinical Center for a levodopa a dopamine agonist dose-finding procedure For this procedure patients stop taking Sinemet and instead have levodopa and subsequently apomorphine infused through a vein During the infusions the drug dose is increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Symptoms are monitored frequently to find the optimal dose Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study
Phase 3 - Active Study Phase
Within 3 months of the dose-finding phase treatment will begin Patients will receive seven doses of JD-1730 or placebo an inactive substance via puffs from an oral spray together with levodopa infusions over a 3-week period The doses are given on days 1 2 and 3 of the first week and then approximately twice a week for the next 2 weeks For these doses patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks All participants will receive placebo at some time during the study and a few patients selected at random will receive only placebo the entire 3 weeks The procedure for the infusions is the same as that for the dose-finding phase with frequent evaluation of symptoms Also small blood samples are drawn up to three times each study day At the end of the third week patients will be discharged from the hospital Their anti-parkinsonian medications may be readjusted as needed Patients will be contacted 2 weeks after the end of the study for a check on side effects and if necessary will be scheduled for a follow-up evaluation at the clinic
In addition to the above procedures patients will be asked to have an optional lumbar a puncture spinal tap on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine For this procedure a local anesthetic is given and a needle is inserted in the space between the bones vertebrae in the lower back About 2 tablespoons of fluid is collected through the needle
Patients between 30 and 80 years of age with relatively advanced Parkinsons disease may be eligible for this 3-phase study
Phase 1 - Baseline evaluation
Participants will be evaluated with a medical history physical examination detailed neurologic evaluation routine blood tests urinalysis and an electrocardiogram They will also have a 24-hour holter monitor heart monitoring and cardiology consultation A chest X-ray and MRI or CT scan of the brain will be done if needed Patients will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration If necessary patients may use short-acting dopamine agonists such as Mirapex and Requip
Phase 2 - Dose Finding Phase
For 2 to 3 days patients will be admitted to the NIH Clinical Center for a levodopa a dopamine agonist dose-finding procedure For this procedure patients stop taking Sinemet and instead have levodopa and subsequently apomorphine infused through a vein During the infusions the drug dose is increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Symptoms are monitored frequently to find the optimal dose Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study
Phase 3 - Active Study Phase
Within 3 months of the dose-finding phase treatment will begin Patients will receive seven doses of JD-1730 or placebo an inactive substance via puffs from an oral spray together with levodopa infusions over a 3-week period The doses are given on days 1 2 and 3 of the first week and then approximately twice a week for the next 2 weeks For these doses patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks All participants will receive placebo at some time during the study and a few patients selected at random will receive only placebo the entire 3 weeks The procedure for the infusions is the same as that for the dose-finding phase with frequent evaluation of symptoms Also small blood samples are drawn up to three times each study day At the end of the third week patients will be discharged from the hospital Their anti-parkinsonian medications may be readjusted as needed Patients will be contacted 2 weeks after the end of the study for a check on side effects and if necessary will be scheduled for a follow-up evaluation at the clinic
In addition to the above procedures patients will be asked to have an optional lumbar a puncture spinal tap on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine For this procedure a local anesthetic is given and a needle is inserted in the space between the bones vertebrae in the lower back About 2 tablespoons of fluid is collected through the needle
Detailed Description:
The objective of this study is to evaluate the effects of selective alpha-2 adrenergic receptor antagonism on the severity of parkinsonian signs and dopaminomimetic drug-associated motor response complications in patients with mild to moderately advanced Parkinsons disease In a controlled proof-of-principle clinical study the acute efficacy of JP-1730 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 |
|---|---|---|---|
| 02-N-0236 | None | None | None |