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Completed

NCT Number: NCT00353665

Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

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).

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurology - Hospital de Santa Maria

Lisbon, 1649-028, Portugal

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Memantine (Ebixa)

Drug

10 mg bid

Other names: Ebixa

Riluzole

Drug

riluzole 50 mg bid

Other names: rilutek

Placebo

Drug

Primary outcomes

  1. ALS-FRS

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jul 19, 2006
Registry last updated
Apr 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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