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

March 1, 2011 updated by: University of Alberta

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Calgary ALS Neuromuscular Clinic
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta ALS Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Memantine Low Dose
Drug: Memantine
Experimental: Memantine High Dose
Drug: Memantine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ALS Functional Rating Scale-Revised (ALSFRS-R)
Forced vital capacity (FVC)
Manual Muscle Testing (MMT)
Addenbrooke Cognitive Examination (ACE)

Secondary Outcome Measures

Outcome Measure
Motor unit number estimates of hand and foot muscles
N-acetylaspartate in the motor cortex

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

ALS Association

Investigators

  • Principal Investigator: Ming Chan, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (Estimate)

December 11, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1204
  • EB2006ALS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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