Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355576
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-07-21
Brief Title:
Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Phase II Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2011-01
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 objective of this study is to compare two combinations of drugs minocycline and creatine or celecoxib and creatine in a phase II trial designed to determine which combination is more effective for ALS
Detailed Description:
Excess free radicals energy mishandling excitotoxicity activation of cell death pathways and inflammation likely all contribute to neurodegeneration in ALS Past trials may have been negative in part because they tested single agents usually influencing only one mechanism of cell death Combinations of agents that affect different and multiple mechanisms of neurodegeneration may be necessary to reach meaningful outcomes in trials of ALS
This trial has several unique features First it compares the neuroprotective potential of two combinations of agents that impact multiple mechanisms of cell death The combinations of minocyclinecreatine and celecoxibcreatine are the only agents that have had additive effects in the mouse model of ALS reducing neurodegeneration and prolonging survival more than individual agents alone Second it uses an important new phase II selection trial design to determine which combination is superior Not only does this trial test combination therapy but there is no placebo so everyone who enrolls in the trial will receive active treatment
Minocycline creatine and celecoxib have been tested individually and have been shown to be safe in patients with ALS This will be the first time human trials will be conducted with combinations of minocyclinecreatine and celecoxibcreatine
We will compare combinations of drugs in a phase II trial design to determine which combination is superior If successful this trial will lead directly to a phase III trial of the selected combination If the design is found useful this trial will lead to larger phase II selection trials assessing greater numbers of agents simultaneously thereby improving the efficiency of drug screening in ALS
This trial has several unique features First it compares the neuroprotective potential of two combinations of agents that impact multiple mechanisms of cell death The combinations of minocyclinecreatine and celecoxibcreatine are the only agents that have had additive effects in the mouse model of ALS reducing neurodegeneration and prolonging survival more than individual agents alone Second it uses an important new phase II selection trial design to determine which combination is superior Not only does this trial test combination therapy but there is no placebo so everyone who enrolls in the trial will receive active treatment
Minocycline creatine and celecoxib have been tested individually and have been shown to be safe in patients with ALS This will be the first time human trials will be conducted with combinations of minocyclinecreatine and celecoxibcreatine
We will compare combinations of drugs in a phase II trial design to determine which combination is superior If successful this trial will lead directly to a phase III trial of the selected combination If the design is found useful this trial will lead to larger phase II selection trials assessing greater numbers of agents simultaneously thereby improving the efficiency of drug screening in ALS
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 |
|---|---|---|---|
| ALSA ID920 | OTHER | CUMC | None |