The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
- Registration Number
- NCT00409721
- Lead Sponsor
- University of Alberta
- Brief Summary
The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Memantine High Dose Memantine - Memantine Low Dose Memantine -
- Primary Outcome Measures
Name Time Method Forced vital capacity (FVC) Manual Muscle Testing (MMT) ALS Functional Rating Scale-Revised (ALSFRS-R) Addenbrooke Cognitive Examination (ACE)
- Secondary Outcome Measures
Name Time Method N-acetylaspartate in the motor cortex Motor unit number estimates of hand and foot muscles
Trial Locations
- Locations (2)
Calgary ALS Neuromuscular Clinic
🇨🇦Calgary, Alberta, Canada
University of Alberta ALS Clinic
🇨🇦Edmonton, Alberta, Canada
Calgary ALS Neuromuscular Clinic🇨🇦Calgary, Alberta, Canada