Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS) - Full Text View

Sponsors and Collaborators:	University of Lisbon H. Lundbeck A/S
Information provided by:	University of Lisbon
ClinicalTrials.gov Identifier:	NCT00353665

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Memantine Memantine hydrochloride Riluzole

U.S. FDA Resources

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
1 - active: Experimental memantine + riluzole	Drug: Memantine (Ebixa) 10 mg bid Drug: riluzole riluzole 50 mg bid
2: Placebo Comparator riluzole + placebo	Drug: riluzole riluzole 50 mg bid 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

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

Locations

Portugal
Department of Neurology - Hospital de Santa Maria
Lisbon, Portugal, 1649-028
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:	Instituto de Medicina Molecular ( Mamede de Carvalho )
Study ID Numbers:	002-04
Study First Received:	July 18, 2006
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00353665 History of Changes
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Keywords provided by University of Lisbon:

amyotrophic lateral sclerosis
motor neuron disease
memantine
clinical trial

Study placed in the following topic categories:

Riluzole
Excitatory Amino Acids
Neurotransmitter Agents
Spinal Cord Diseases
Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Neuroprotective Agents
Dopamine

Neuromuscular Diseases
Lou Gehrig's Disease
Amyotrophic Lateral Sclerosis
Memantine
Dopamine Agents
Motor Neuron Disease
Degenerative Motor System Disease
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Spinal Cord Diseases
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Neurodegenerative Diseases
Neuroprotective Agents
Pathologic Processes
Neuromuscular Diseases
Therapeutic Uses
Memantine

Motor Neuron Disease
Excitatory Amino Acid Antagonists
Riluzole
Nervous System Diseases
Central Nervous System Diseases
Sclerosis
Protective Agents
Pharmacologic Actions
Amyotrophic Lateral Sclerosis
Dopamine Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 03, 2009