Amyotrophic Lateral Sclerosis
Conditions
Keywords
Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND, Memantine
Brief summary
The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.
Interventions
DRUGMemantine
Sponsors
ALS Association
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALS Functional Rating Scale-Revised (ALSFRS-R) | — |
| Forced vital capacity (FVC) | — |
| Manual Muscle Testing (MMT) | — |
| Addenbrooke Cognitive Examination (ACE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor unit number estimates of hand and foot muscles | — |
| N-acetylaspartate in the motor cortex | — |
Countries
Canada
Outcome results
None listed