Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353665
Status:
COMPLETED
Last Update Posted:
2009-04-01
First Post:
2006-07-18
Brief Title:
Memantine for Disability in Amyotrophic Lateral Sclerosis MEDALS
Sponsor:
University of Lisbon
Organization:
University of Lisbon
Study Overview
Official Title:
Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2009-03
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 purpose of this trial is to study the effect of Memantine uncompetitive moderate affinity NMDA receptor antagonist that binds to the NMDA receptor channel and regulates the calcium influx into the neurons a drug used to treat Alzheimers disease on the progression of Amyotrophic Lateral Sclerosis ALS Memantine is added to riluzole the single drug approved to treat ALS
Detailed Description:
Phase 23 trial in ALS patients Double-blinded parallel randomized 2 blocs bulbarspinal onset
Memantine riluzole x Placebo Memantine
Inclusion criteria
75 years at disease onset
3 years of disease progression
ALS-FRS 24
FVC 60
Probable or definite disease revised El Escorial criteria
No other medical condition
Normal blood tests
Regular medication on riluzole 1 month
Nerve conduction studies ruling out conduction block
EMG with widespread loss of motor units revised El Escorial criteria
At least one hand with ADM strength 2 on MRC scale
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36 Hamilton depression scale motor unit number estimation neurophysiological index strength clinical evaluation side-effects
Intention to treat analysis
60 patients
number estimated for 50 change in decline rate of ALS-FRS
Memantine riluzole x Placebo Memantine
Inclusion criteria
75 years at disease onset
3 years of disease progression
ALS-FRS 24
FVC 60
Probable or definite disease revised El Escorial criteria
No other medical condition
Normal blood tests
Regular medication on riluzole 1 month
Nerve conduction studies ruling out conduction block
EMG with widespread loss of motor units revised El Escorial criteria
At least one hand with ADM strength 2 on MRC scale
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36 Hamilton depression scale motor unit number estimation neurophysiological index strength clinical evaluation side-effects
Intention to treat analysis
60 patients
number estimated for 50 change in decline rate of ALS-FRS
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