Trial | NCT00353665  Report issue

Title

Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
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).
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 Started
Jul 31
2005
Primary Completion
Jun 30
2008
Study Completion
Jan 31
2009
Last Update
Apr 01
2009
Estimate

Drug Memantine (Ebixa)

10 mg bid

  • Other names: Ebixa

Drug riluzole

riluzole 50 mg bid

  • Other names: rilutek

Drug Placebo

1 - active Experimental

memantine + riluzole

2 Placebo Comparator

riluzole + placebo

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%
No Results Posted