Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALS
Sponsor:
Brief Summary:
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
Criteria
1. Age 18-85
2. Male or Female
3. Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial
criteria
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
Locations
- UC Irvine, Irvine, California, United States, 92868
