Therapy in Amyotrophic Lateral Sclerosis (TAME)

• Status: Completed
• Trial end date: 2021-07-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: University of Missouri-Columbia
• Treatments: Memantine

Criteria

Inclusion 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