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

A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS

Sponsors

Lead Sponsor: University of Alberta

Collaborator: ALS Association

Source University of Alberta
Brief Summary

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

Overall Status Completed
Start Date March 2007
Completion Date December 2010
Primary Completion Date December 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
ALS Functional Rating Scale-Revised (ALSFRS-R)
Forced vital capacity (FVC)
Manual Muscle Testing (MMT)
Addenbrooke Cognitive Examination (ACE)
Secondary Outcome
Measure Time Frame
Motor unit number estimates of hand and foot muscles
N-acetylaspartate in the motor cortex
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Memantine

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
Calgary ALS Neuromuscular Clinic | Calgary, Alberta, T2N 4N1, Canada
University of Alberta ALS Clinic | Edmonton, Alberta, T6G 2B7, Canada
Location Countries

Canada

Verification Date

March 2011

Responsible Party

Name Title: Sanjay Kalra, MD

Organization: University of Alberta

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Memantine Low Dose

Type: Experimental

Label: Memantine High Dose

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov