The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in ALS - Full Text View

The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in ALS

This study is currently recruiting participants.
Verified by University of Alberta, May 2008

Sponsors and Collaborators:	University of Alberta ALS Association
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00409721

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 II

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis

Drug Information available for:

Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

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

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
Estimated Study Completion Date:	December 2008

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 70% 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

Contacts


Contact: Meredith Lynch, B.Sc., CCRP	(780) 407-2944	meredith.lynch@ualberta.ca

Locations


Canada, Alberta
	University of Alberta ALS Clinic	Recruiting
	Edmonton, Alberta, Canada, T6G 2B7
	Principal Investigator: Ming Chan, MD
	Principal Investigator: Sanjay Kalra, MD
	Calgary ALS Neuromuscular Clinic	Recruiting
	Calgary, Alberta, Canada, T2N 4N1
	Contact: Susan Wood, RN 403-220-3504 swood@ucalgary.ca
	Principal Investigator: Chris White, MD
	Sub-Investigator: Cory Toth, MD

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

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

Responsible Party:	University of Alberta ( Sanjay Kalra, MD )
Study ID Numbers:	1204, EB2006ALS
First Received:	December 8, 2006
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00409721
Health Authority:	Canada: Health Canada

Keywords provided by University of Alberta:

Amyotrophic Lateral Sclerosis

ALS

Motor Neuron Disease

MND

Memantine

Study placed in the following topic categories:

Excitatory Amino Acids

Spinal Cord Diseases

Central Nervous System Diseases

Sclerosis

Degenerative motor system disease

Neurodegenerative Diseases

Motor neuron disease

Nerve Degeneration

Dopamine

Amyotrophic lateral sclerosis

Neuromuscular Diseases

Amyotrophic Lateral Sclerosis

Memantine

Lou Gehrig's disease

Motor Neuron Disease

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Nervous System Diseases

Physiological Effects of Drugs

Antiparkinson Agents

Excitatory Amino Acid Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 22, 2008