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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409721
First Posted: December 11, 2006
Last Update Posted: March 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ALS Association
Information provided by:
University of Alberta
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
  • Forced vital capacity (FVC)
  • Manual Muscle Testing (MMT)
  • Addenbrooke Cognitive Examination (ACE)

Secondary Outcome Measures:
  • Motor unit number estimates of hand and foot muscles
  • N-acetylaspartate in the motor cortex

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409721


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00409721     History of Changes
Other Study ID Numbers: 1204
EB2006ALS
First Submitted: December 8, 2006
First Posted: December 11, 2006
Last Update Posted: March 2, 2011
Last Verified: March 2011

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

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