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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Memantine
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND, Memantine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary ALS Neuromuscular Clinic
  • University of Alberta ALS Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Memantine Low Dose

Memantine High Dose

Arm Description

Outcomes

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

Full Information

First Posted
December 8, 2006
Last Updated
March 1, 2011
Sponsor
University of Alberta
Collaborators
ALS Association
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1. Study Identification

Unique Protocol Identification Number
NCT00409721
Brief Title
The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
ALS Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND, Memantine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memantine Low Dose
Arm Type
Experimental
Arm Title
Memantine High Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Memantine
Primary Outcome Measure Information:
Title
ALS Functional Rating Scale-Revised (ALSFRS-R)
Title
Forced vital capacity (FVC)
Title
Manual Muscle Testing (MMT)
Title
Addenbrooke Cognitive Examination (ACE)
Secondary Outcome Measure Information:
Title
Motor unit number estimates of hand and foot muscles
Title
N-acetylaspartate in the motor cortex

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Chan, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay Kalra, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary ALS Neuromuscular Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta ALS Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.alsa.org
Description
ALS Association of America (ALSA)
URL
http://www.alsab.ca/
Description
ALS Society of Alberta
URL
http://www.als.ca/
Description
ALS Society of Canada

Learn more about this trial

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

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