Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140218
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2005-08-30
Brief Title:
R Pramipexole in Early Amyotrophic Lateral Sclerosis
Sponsor:
Bennett James P Jr MD PhD
Organization:
Bennett James P Jr MD PhD
Study Overview
Official Title:
Futility Study of R Pramipexole in Early Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this study is that treatment with R pramipexole at 30 mgday will alter the slope of decline in ALS functional rating scale over the course of 6 months ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months
Detailed Description:
This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS The drug to be tested is R pramipexole an antioxidant that concentrates into brain and mitochondria RPPX will be administered at 30 mgday over 6 months following a 3 month lead-in period without drug therapy For purposes of this study futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40
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