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

University of Alberta

Status and phase: Completed; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Memantine

Study type: Interventional

Funder types: Other

Identifiers

NCT00409721

EB2006ALS

1204

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Memantine Low Dose

Experimental group

Treatment:

Drug: Memantine

Memantine High Dose

Experimental group

Treatment:

Drug: Memantine