NCT00353665

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

2.9 years

First QC Date

July 18, 2006

Last Update Submit

March 30, 2009

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosismotor neuron diseasememantineclinical trial

Outcome Measures

Primary Outcomes (1)

  • ALS-FRS

    12 months

Secondary Outcomes (2)

  • QoL, depression scale, strength (clinical evaluation), forced vital capacity

    12 months

  • neurophysiology (motor unit counting, neurophysiological index)

    12 months

Study Arms (2)

1 - active

EXPERIMENTAL

memantine + riluzole

Drug: Memantine (Ebixa)Drug: riluzole

2

PLACEBO COMPARATOR

riluzole + placebo

Drug: riluzoleDrug: Placebo

Interventions

Memantine (Ebixa)DRUG

10 mg bid

Also known as: Ebixa
1 - active
riluzoleDRUG

riluzole 50 mg bid

Also known as: rilutek
1 - active2
PlaceboDRUG
2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology - Hospital de Santa Maria

Lisbon, 1649-028, Portugal

Location

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisMotor Neuron Disease

Interventions

MemantineRiluzole

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiazolesSulfur CompoundsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mamede de Carvalho, MD

    Department of Neurology- Hospital de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

July 1, 2005

Primary Completion

June 1, 2008

Study Completion

January 1, 2009

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

PT(1)