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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:
Collaborator:
ALS Association
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00409721
First received: December 8, 2006
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
University of Alberta ALS Clinic  This link exits the ClinicalTrials.gov site
ALS Association of America (ALSA)  This link exits the ClinicalTrials.gov site
ALS Society of Alberta  This link exits the ClinicalTrials.gov site
ALS Society of Canada  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanjay Kalra, MD, University of Alberta
ClinicalTrials.gov 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
ALS
Motor Neuron Disease
MND
Memantine

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

ClinicalTrials.gov processed this record on June 18, 2013