Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029874
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-24
Brief Title:
Minocycline in Patients With Huntingtons Disease
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Minocycline Dosing and Safety in Huntingtons Disease
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine whether treatment with minocycline is safe and tolerable in patients with Huntingtons disease HD and whether minocycline reduces symptoms of HD in these patients
Detailed Description:
Huntingtons disease HD is a dominantly inherited disorder It is uniformly progressive and there is no known effective treatment or cure The pathogenesis is largely unknown however recent studies implicate caspase activation glutamate excitotoxicity and free radical toxicity as possible causes of HD Pharmacological agents that block these pathways may be therapeutic in HD Minocycline is an antibiotic that also inhibits caspase-1 and caspase-3 expression and inducible nitric oxide synthetase activity which are factors that may play an important role in the mechanisms of neuropathology in HD
Two dosages of minocycline or placebo will be given to ambulatory patients with HD over an 8-week period and the tolerability will be compared Additional measures of safety and the change in motor behavior cognitive and function features will be examined
Two dosages of minocycline or placebo will be given to ambulatory patients with HD over an 8-week period and the tolerability will be compared Additional measures of safety and the change in motor behavior cognitive and function features will be examined
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