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

NCT ID: NCT00409721

Last Updated: 2011-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Memantine Low Dose

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Memantine High Dose

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Interventions

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Memantine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALS Association

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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University of Alberta

Principal Investigators

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Ming Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Sanjay Kalra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Calgary ALS Neuromuscular Clinic

Calgary, Alberta, Canada

Site Status

University of Alberta ALS Clinic

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Related Links

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http://www.alsa.org

ALS Association of America (ALSA)

http://www.alsab.ca/

ALS Society of Alberta

http://www.als.ca/

ALS Society of Canada

Other Identifiers

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EB2006ALS

Identifier Type: -

Identifier Source: secondary_id

1204

Identifier Type: -

Identifier Source: org_study_id

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