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

Phase 2CompletedNCT00409721

University of Alberta42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

MemantineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Calgary ALS Neuromuscular Clinic

Calgary, Alberta, Canada

University of Alberta ALS Clinic

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

ALS Functional Rating Scale-Revised (ALSFRS-R)

Forced vital capacity (FVC)

Manual Muscle Testing (MMT)

Addenbrooke Cognitive Examination (ACE)

Secondary Outcomes

Motor unit number estimates of hand and foot muscles

N-acetylaspartate in the motor cortex

Data from ClinicalTrials.gov

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