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

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyotrophic Lateral Sclerosis

Intervention: Memantine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Ming Chan, MD, Principal Investigator, Affiliation: University of Alberta
Sanjay Kalra, MD, Principal Investigator, Affiliation: University of Alberta

Summary

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

Clinical Details

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

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

Primary outcome:

ALS Functional Rating Scale-Revised (ALSFRS-R)

Forced vital capacity (FVC)

Manual Muscle Testing (MMT)

Addenbrooke Cognitive Examination (ACE)

Secondary outcome:

Motor unit number estimates of hand and foot muscles

N-acetylaspartate in the motor cortex

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Calgary ALS Neuromuscular Clinic, Calgary, Alberta T2N 4N1, Canada

University of Alberta ALS Clinic, Edmonton, Alberta T6G 2B7, Canada

Additional Information

University of Alberta ALS Clinic

ALS Association of America (ALSA)

ALS Society of Alberta

ALS Society of Canada

Starting date: March 2007
Last updated: March 1, 2011

Page last updated: August 23, 2015

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