The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS
2 other identifiers
interventional
42
1 country
2
Brief Summary
The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2006
CompletedFirst Posted
Study publicly available on registry
December 11, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 2, 2011
March 1, 2011
3.8 years
December 8, 2006
March 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
ALS Functional Rating Scale-Revised (ALSFRS-R)
Forced vital capacity (FVC)
Manual Muscle Testing (MMT)
Addenbrooke Cognitive Examination (ACE)
Secondary Outcomes (2)
Motor unit number estimates of hand and foot muscles
N-acetylaspartate in the motor cortex
Study Arms (2)
Memantine Low Dose
EXPERIMENTALMemantine High Dose
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- El Escorial Classification of laboratory supported probable, probable,or definite ALS
- Age 18 - 80 years,
- ALS symptoms for no more than 3 years,
- FVC greater than or equal to 60% predicted,
- Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
- Patients must have the ability to attend monthly study visits in Edmonton or Calgary, Alberta
You may not qualify if:
- Presence of significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness
- Female patients who are breastfeeding
- Use of concurrent investigational drugs,
- Patient unlikely to comply with study requirements
- Poor adherence to study protocol during run-in phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- ALS Associationcollaborator
Study Sites (2)
Calgary ALS Neuromuscular Clinic
Calgary, Alberta, T2N 4N1, Canada
University of Alberta ALS Clinic
Edmonton, Alberta, T6G 2B7, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Chan, MD
University of Alberta
- PRINCIPAL INVESTIGATOR
Sanjay Kalra, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 8, 2006
First Posted
December 11, 2006
Study Start
March 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 2, 2011
Record last verified: 2011-03