The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: Memantine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Alberta Official(s) and/or principal investigator(s): Ming Chan, MD, Principal Investigator, Affiliation: University of Alberta Sanjay Kalra, MD, Principal Investigator, Affiliation: University of Alberta
Summary
The purpose of the study is to investigate the effects of memantine in ALS patients using
functional outcome measures.
Clinical Details
Official title: A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ALS Functional Rating Scale-Revised (ALSFRS-R)Forced vital capacity (FVC) Manual Muscle Testing (MMT) Addenbrooke Cognitive Examination (ACE)
Secondary outcome: Motor unit number estimates of hand and foot musclesN-acetylaspartate in the motor cortex
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Calgary ALS Neuromuscular Clinic, Calgary, Alberta T2N 4N1, Canada
University of Alberta ALS Clinic, Edmonton, Alberta T6G 2B7, Canada
Additional Information
University of Alberta ALS Clinic ALS Association of America (ALSA) ALS Society of Alberta ALS Society of Canada
Starting date: March 2007
Last updated: March 1, 2011
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