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

This study has been completed.
Sponsor:
Collaborator:
ALS Association
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00409721
First received: December 8, 2006
Last updated: March 1, 2011
Last verified: March 2011
History of Changes

December 8, 2006
March 1, 2011
March 2007
December 2010   (final data collection date for primary outcome measure)
  • ALS Functional Rating Scale-Revised (ALSFRS-R) [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Designated as safety issue: No ]
  • Manual Muscle Testing (MMT) [ Designated as safety issue: No ]
  • Addenbrooke Cognitive Examination (ACE) [ Designated as safety issue: No ]
  • ALS Functional Rating Scale-Revised (ALSFRS-R)
  • Forced vital capacity (FVC)
  • Manual Muscle Testing (MMT)
  • Addenbrooke Cognitive Examination (ACE)
Complete list of historical versions of study NCT00409721 on ClinicalTrials.gov Archive Site
  • Motor unit number estimates of hand and foot muscles [ Designated as safety issue: No ]
  • N-acetylaspartate in the motor cortex [ Designated as safety issue: No ]
  • Motor unit number estimates of hand and foot muscles
  • N-acetylaspartate in the motor cortex
Not Provided
Not Provided
 
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

The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Drug: Memantine
  • Experimental: Memantine Low Dose
    Intervention: Drug: Memantine
  • Experimental: Memantine High Dose
    Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00409721
1204, EB2006ALS
Yes
Sanjay Kalra, MD, University of Alberta
University of Alberta
ALS Association
Principal Investigator: Ming Chan, MD University of Alberta
Principal Investigator: Sanjay Kalra, MD University of Alberta
University of Alberta
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP