The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
ALS Association
Information provided by:
University of Alberta Identifier:
First received: December 8, 2006
Last updated: March 1, 2011
Last verified: March 2011
The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Memantine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • ALS Functional Rating Scale-Revised (ALSFRS-R) [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Designated as safety issue: No ]
  • Manual Muscle Testing (MMT) [ Designated as safety issue: No ]
  • Addenbrooke Cognitive Examination (ACE) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor unit number estimates of hand and foot muscles [ Designated as safety issue: No ]
  • N-acetylaspartate in the motor cortex [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine Low Dose Drug: Memantine
Experimental: Memantine High Dose Drug: Memantine


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00409721

Canada, Alberta
Calgary ALS Neuromuscular Clinic
Calgary, Alberta, Canada, T2N 4N1
University of Alberta ALS Clinic
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
ALS Association
Principal Investigator: Ming Chan, MD University of Alberta
Principal Investigator: Sanjay Kalra, MD University of Alberta
  More Information

Additional Information:
Responsible Party: Sanjay Kalra, MD, University of Alberta Identifier: NCT00409721     History of Changes
Other Study ID Numbers: 1204  EB2006ALS 
Study First Received: December 8, 2006
Last Updated: March 1, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Nerve Degeneration
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 22, 2016