Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009048
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-01-23
Brief Title:
EMD 128130 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:
Effect of Serotoninergic Treatment in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2003-12
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 EMD 128130 on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term treatment with levodopa EMD 128130 inhibits the function of serotonin a chemical messenger thought to regulate dopamine release and thus affect Parkinsons disease symptoms
Patients with relatively advanced Parkinsons disease between 30 and 80 years of age may be eligible for this 3-phase study
Phase 1 - Baseline Evaluation
Participants will have a medical history physical examination detailed neurologic evaluation routine blood tests urinalysis and an electrocardiogram A chest X-ray and MRI or CT scan of the brain will be done if needed In addition an ACTH stimulation test will be done before and at the end of the study For this test a hormone called ACTH is injected into a vein A small amount of blood is drawn before the injection and 30 and 60 minutes afterwards to measure levels of another hormone called cortisol After these tests are completed patients will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration
Phase 2 - Levodopa and Apomorphine Dose Finding
For 1 to 3 days patients will be admitted to the NIH Clinical center to undergo a levodopa and apomorphine a dopamine agonist dose-finding procedure For this procedure patients will stop taking Sinemet and instead will have levodopa and subsequently apomorphine infused through a vein 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
Phase 3 - Active Study
Patients will begin the treatment phase within 3 months of the dose-finding phase After a brief physical examination routine blood tests and evaluation of parkinsonism symptoms patients will begin taking either EMD 128130 tablets or capsules or a placebo a look-alike pill with no active ingredient twice a day along with Sinemet for 3 weeks All participants will receive placebo at least 1 week during the study and about four patients selected at random will receive only placebo the entire 3 weeks Levodopa and apomorphine infusions will be repeated at the end of weeks 1 2 and 3 of Phase 3 The procedure for the infusions will be the same as in the dose-finding phase
Throughout the study parkinsonian symptoms and dyskinesias will be assessed and blood samples will be drawn periodically to measure drug levels Patients will return for a follow-up evaluation 2 weeks after the end of the study
Patients with relatively advanced Parkinsons disease between 30 and 80 years of age may be eligible for this 3-phase study
Phase 1 - Baseline Evaluation
Participants will have a medical history physical examination detailed neurologic evaluation routine blood tests urinalysis and an electrocardiogram A chest X-ray and MRI or CT scan of the brain will be done if needed In addition an ACTH stimulation test will be done before and at the end of the study For this test a hormone called ACTH is injected into a vein A small amount of blood is drawn before the injection and 30 and 60 minutes afterwards to measure levels of another hormone called cortisol After these tests are completed patients will if possible stop taking all antiparkinsonian medications except levodopa Sinemet for one month before the study begins and throughout its duration
Phase 2 - Levodopa and Apomorphine Dose Finding
For 1 to 3 days patients will be admitted to the NIH Clinical center to undergo a levodopa and apomorphine a dopamine agonist dose-finding procedure For this procedure patients will stop taking Sinemet and instead will have levodopa and subsequently apomorphine infused through a vein 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
Phase 3 - Active Study
Patients will begin the treatment phase within 3 months of the dose-finding phase After a brief physical examination routine blood tests and evaluation of parkinsonism symptoms patients will begin taking either EMD 128130 tablets or capsules or a placebo a look-alike pill with no active ingredient twice a day along with Sinemet for 3 weeks All participants will receive placebo at least 1 week during the study and about four patients selected at random will receive only placebo the entire 3 weeks Levodopa and apomorphine infusions will be repeated at the end of weeks 1 2 and 3 of Phase 3 The procedure for the infusions will be the same as in the dose-finding phase
Throughout the study parkinsonian symptoms and dyskinesias will be assessed and blood samples will be drawn periodically to measure drug levels Patients will return for a follow-up evaluation 2 weeks after the end of the study
Detailed Description:
The objective of this study is to evaluate the acute effects of a selective agonist of serotonin 5-HT1A receptors 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 EMD 128130 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-0071 | None | None | None |