Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047723
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2002-10-16
Brief Title:
Minocycline to Treat Amyotrophic Lateral Sclerosis
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The purpose of this trial is to test the safety tolerability and effectiveness of minocycline compared to placebo in patients with amyotrophic lateral sclerosis ALS
Detailed Description:
ALS is a progressive neurodegenerative disorder without cure or known treatment that significantly improves function Loss of motor neurons in the brain and spinal cord of ALS patients causes the progressive symptoms Laboratory studies have linked inducible nitric oxide synthase iNOS and caspase enzyme activation to motor nerve cell death in ALS Minocycline-a medication currently approved by the FDA for treatment of bacterial infections-is a tetracycline antibiotic with high central nervous system penetration when taken orally The drug inhibits the activity of iNOS and caspase enzymes
Minocycline has been tested and shown to protect nerve cells in many scientific experiments It reduces cell death and prolongs survival in animal models of ALS stroke trauma Huntingtons disease and Parkinsons disease It has been shown to be beneficial in many different animal experiments of ALS conducted in Europe Canada and the United States
Minocycline has been tested in 2 preliminary human trials and has been shown to be safe in patients with ALS It has been well tolerated in conjunction with riluzole Rilutek the only currently FDA-approved medication for ALS
This trial is the final important step in determining whether minocycline improves the course of ALS The principle objective of this clinical trial is to determine whether minocycline slows disease progression and helps maintain function in patients with ALS This multi-center placebo-controlled study will select patients early in the course of ALS when a neuroprotective therapy may be most beneficial The study will measure change in function as detected by ALSFRS-R scores strength pulmonary function survival and quality of life Participants will undergo monthly outpatient evaluations and analysis of laboratory and adverse events This is a 13-month study
Minocycline has been tested and shown to protect nerve cells in many scientific experiments It reduces cell death and prolongs survival in animal models of ALS stroke trauma Huntingtons disease and Parkinsons disease It has been shown to be beneficial in many different animal experiments of ALS conducted in Europe Canada and the United States
Minocycline has been tested in 2 preliminary human trials and has been shown to be safe in patients with ALS It has been well tolerated in conjunction with riluzole Rilutek the only currently FDA-approved medication for ALS
This trial is the final important step in determining whether minocycline improves the course of ALS The principle objective of this clinical trial is to determine whether minocycline slows disease progression and helps maintain function in patients with ALS This multi-center placebo-controlled study will select patients early in the course of ALS when a neuroprotective therapy may be most beneficial The study will measure change in function as detected by ALSFRS-R scores strength pulmonary function survival and quality of life Participants will undergo monthly outpatient evaluations and analysis of laboratory and adverse events This is a 13-month study
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