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Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Lisbon
ClinicalTrials.gov Identifier:
NCT00353665
First received: July 18, 2006
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Memantine (Ebixa)
Drug: riluzole
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Lisbon:

Primary Outcome Measures:
  • ALS-FRS [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QoL, depression scale, strength (clinical evaluation), forced vital capacity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • neurophysiology (motor unit counting, neurophysiological index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2005
Study Completion Date: January 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353665

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

No publications provided

Responsible Party: Mamede de Carvalho, Instituto de Medicina Molecular
ClinicalTrials.gov Identifier: NCT00353665     History of Changes
Other Study ID Numbers: 002-04
Study First Received: July 18, 2006
Last Updated: March 30, 2009
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by University of Lisbon:
amyotrophic lateral sclerosis
motor neuron disease
memantine
clinical trial

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Memantine
Riluzole
Anti-Dyskinesia Agents
Anticonvulsants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014