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Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353665
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : April 1, 2009
H. Lundbeck A/S
Information provided by:
University of Lisbon

Brief Summary:
The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Memantine (Ebixa) Drug: riluzole Drug: Placebo Phase 2 Phase 3

Detailed Description:

Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)

Memantine + riluzole x Placebo + Memantine

Inclusion criteria:

  • < 75 years at disease onset
  • < 3 years of disease progression
  • ALS-FRS > 24
  • FVC > 60
  • Probable or definite disease (revised El Escorial criteria)
  • No other medical condition
  • Normal blood tests
  • Regular medication on riluzole > 1 month
  • Nerve conduction studies ruling out conduction block
  • EMG with widespread loss of motor units (revised El Escorial criteria)
  • At least one hand with ADM strength > 2 on MRC scale

Duration - 2 years

Evaluation - every 3 months

Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects

Intention to treat analysis

60 patients

number estimated for 50% change in decline rate of ALS-FRS

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
Study Start Date : July 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 1 - active
memantine + riluzole
Drug: Memantine (Ebixa)
10 mg bid
Other Name: Ebixa

Drug: riluzole
riluzole 50 mg bid
Other Name: rilutek

Placebo Comparator: 2
riluzole + placebo
Drug: riluzole
riluzole 50 mg bid
Other Name: rilutek

Drug: Placebo

Primary Outcome Measures :
  1. ALS-FRS [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. QoL, depression scale, strength (clinical evaluation), forced vital capacity [ Time Frame: 12 months ]
  2. neurophysiology (motor unit counting, neurophysiological index) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Definite or probable disease - revise El Escorial criteria
  • Normal blood tests
  • Riluzole treatment during 1 month or more
  • EMG in accordance with El Escorial criteria

Exclusion Criteria:

  • Other diseases (such as PNP)
  • Both ADM muscles < 3 on MRC scale
  • Conduction block on nerve conduction tests
  • Disease duration > 3 years
  • ALS-FRS < 25
  • Forced vital capacity - <60%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353665

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Department of Neurology - Hospital de Santa Maria
Lisbon, Portugal, 1649-028
Sponsors and Collaborators
University of Lisbon
H. Lundbeck A/S
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Principal Investigator: Mamede de Carvalho, MD Department of Neurology- Hospital de Santa Maria

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Responsible Party: Mamede de Carvalho, Instituto de Medicina Molecular Identifier: NCT00353665    
Other Study ID Numbers: 002-04
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009
Keywords provided by University of Lisbon:
amyotrophic lateral sclerosis
motor neuron disease
clinical trial
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neuroprotective Agents
Protective Agents