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

This study is currently recruiting participants.

Verified by University of Alberta, July 2009

First Received: December 8, 2006 Last Updated: July 15, 2009 History of Changes

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

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

Resource links provided by NLM:

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

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 2009

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

Contacts

Contact: Ramnik Sekhon, B.Sc.

(780) 407-2944

rsekhon@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: Shefina Mawani, RN 403-220-3504 shefina.mawani@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

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:	University of Alberta ( Sanjay Kalra, MD )
Study ID Numbers:	1204, EB2006ALS
Study First Received:	December 8, 2006
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00409721 History of Changes
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
Neurotransmitter Agents
Spinal Cord Diseases
Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Nerve Degeneration
Dopamine

Neuromuscular Diseases
Lou Gehrig's Disease
Amyotrophic Lateral Sclerosis
Memantine
Dopamine Agents
Motor Neuron Disease
Degenerative Motor System Disease

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Excitatory Amino Acid Agents
Sclerosis
Neurodegenerative Diseases

Pharmacologic Actions
Nerve Degeneration
Pathologic Processes
Neuromuscular Diseases
Amyotrophic Lateral Sclerosis
Therapeutic Uses
Memantine
Dopamine Agents
Central Nervous System Agents
Motor Neuron Disease
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 01, 2009