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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409721
• Other study ID #: 1204
• Secondary ID: EB2006ALS
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2006
• Last updated: March 1, 2011
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Nerve Degeneration
• Sclerosis

Intervention

Drug:
• Memantine

Locations

Country	Name	City	State
Canada	Calgary ALS Neuromuscular Clinic	Calgary	Alberta
Canada	University of Alberta ALS Clinic	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	ALS Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALS Functional Rating Scale-Revised (ALSFRS-R)			No
Primary	Forced vital capacity (FVC)			No
Primary	Manual Muscle Testing (MMT)			No
Primary	Addenbrooke Cognitive Examination (ACE)			No
Secondary	Motor unit number estimates of hand and foot muscles			No
Secondary	N-acetylaspartate in the motor cortex			No

External Links

•   ALS Association of America (ALSA)
•   ALS Society of Alberta
•   ALS Society of Canada
•   University of Alberta ALS Clinic