Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063193
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2003-06-23
Brief Title:
National Institute of Neurological Disorders and Stroke NINDS Parkinsons Disease Neuroprotection Trial
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Multi-center Double-blind Pilot Study of Minocycline and Creatine in Subjects With Early Untreated Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The goal of this study is to assess the impact of minocycline and creatine on the progression of Parkinsons disease in order to determine whether it is reasonable to proceed with further study of either of these agents
Detailed Description:
Parkinsons disease PD affects nearly a million Americans a number that will increase over the coming decades as the population ages While available medical therapies are usually effective for controlling symptoms in the initial years following diagnosis higher doses of multiple agents are required over time with increasing side effects and incomplete control of symptoms Although these treatments can dramatically improve the lives of patients with PD initially they do not address the underlying causes of the disease or the inevitable disease progression
This multi-center randomized double-blind trial will involve 42 trial centers in the United States and Canada and enroll 195 people with PD The primary objective of this neuroprotection trial is to identify agents capable of slowing the progression of PD In the trial investigators will assess the impact of minocycline and creatine on the progression of PD and determine if it is futile or non-futile to proceed with further study of these agents
In this study subjects with early untreated PD will be equally randomized into one of the three study arms 1 the group that receives active minocycline and placebo instead of creatine 2 the group that receives active creatine and placebo instead of minocycline or 3 the group that receives placebo instead of minocycline and creatine Subjects will remain on the blinded study drug for 18 months
This multi-center randomized double-blind trial will involve 42 trial centers in the United States and Canada and enroll 195 people with PD The primary objective of this neuroprotection trial is to identify agents capable of slowing the progression of PD In the trial investigators will assess the impact of minocycline and creatine on the progression of PD and determine if it is futile or non-futile to proceed with further study of these agents
In this study subjects with early untreated PD will be equally randomized into one of the three study arms 1 the group that receives active minocycline and placebo instead of creatine 2 the group that receives active creatine and placebo instead of minocycline or 3 the group that receives placebo instead of minocycline and creatine Subjects will remain on the blinded study drug for 18 months
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