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Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALS


Brief Summary:

The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction
with riluzole, can slow down the disease progression of patients with ALS including
potentially improving their neuropsychiatric changes, as well as determine if serum
biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS.

Funding Source: FDA-OPD


Inclusion Criteria:

1. Age 18-85

2. Male or Female

3. Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial

4. ALSFRS-R > 25

5. Must be willing to undergo longitudinal blood draws for biomarker analysis

6. Must have a caregiver

7. Availability and willingness to complete the study

8. Capable of providing informed consent and complying with trial procedures

9. If patients are taking riluzole and/or Radicava, they must be a on a stable dose for
at least thirty days prior to the baseline.

Exclusion Criteria:

1. Patients with FVC ≤ 60%

2. History of liver disease

3. Severe renal failure

4. History of intolerance to memantine

5. Onset of weakness for greater than 3 years

6. Any other co-morbid condition which would make completion of the trial unlikely

7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to
use birth control.

8. Taking any trial medications. Non-trial medications are not cause for exclusion.

9. Unwillingness to provide consent


  • UC Irvine, Irvine, California, United States, 92868
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