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

Verified by: University of Alberta, March 2011
First Received: December 8, 2006 | Last Updated: March 1, 2011 | Phase: Phase 2 | Start Date: March 2007
Overall Status: Completed | Estimated Enrollment: 42
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The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures...

Brief Summary

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”

The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.

  • 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
  • Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

  • Drug: Memantine

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Memantine Low Dose
  • Experimental: Memantine High Dose

Outcome Measures for this Clinical Trial

Primary Measures

  • ALS Functional Rating Scale-Revised (ALSFRS-R)
    • Safety Issue?: No
  • Forced vital capacity (FVC)
    • Safety Issue?: No
  • Manual Muscle Testing (MMT)
    • Safety Issue?: No
  • Addenbrooke Cognitive Examination (ACE)
    • Safety Issue?: No

Secondary Measures

  • Motor unit number estimates of hand and foot muscles
    • Safety Issue?: No
  • N-acetylaspartate in the motor cortex
    • Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: University of Alberta Other

Overall Clinical Trial Officials and Contacts

Ming Chan, MD Principal Investigator University of Alberta  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00409721

Study ID Number: 1204

ClinicalTrials.gov Identifier: NCT00409721

Health Authority: Canada: Health Canada

University of Alberta ALS Clinic

ALS Association of America (ALSA)

ALS Society of Alberta

ALS Society of Canada

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00409721