Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353665
• Other study ID #: 002-04
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 18, 2006
• Last updated: March 30, 2009
• Start date: July 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Memantine (Ebixa)
10 mg bid
• riluzole
riluzole 50 mg bid
• Placebo

Locations

Country	Name	City	State
Portugal	Department of Neurology - Hospital de Santa Maria	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
University of Lisbon	H. Lundbeck A/S

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALS-FRS		12 months	Yes
Secondary	QoL, depression scale, strength (clinical evaluation), forced vital capacity		12 months	Yes
Secondary	neurophysiology (motor unit counting, neurophysiological index)		12 months	No