Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

March 30, 2009 updated by: University of Lisbon

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1649-028
        • Department of Neurology - Hospital de Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 - active
memantine + riluzole
Drug: Memantine (Ebixa)
10 mg bid
Other Names:
  • Ebixa
Drug: riluzole
riluzole 50 mg bid
Other Names:
  • rilutek
Placebo Comparator: 2
riluzole + placebo
Drug: Placebo
Drug: riluzole
riluzole 50 mg bid
Other Names:
  • rilutek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ALS-FRS
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
QoL, depression scale, strength (clinical evaluation), forced vital capacity
Time Frame: 12 months
12 months
neurophysiology (motor unit counting, neurophysiological index)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Mamede de Carvalho, MD, Department of Neurology- Hospital de Santa Maria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Estimate)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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