Therapy in Amyotrophic Lateral Sclerosis (TAME)

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis, Frontal Temporal Dementia

In brief

The purpose of this study is to determine if memantine at up to 20 mg twice a day 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 - Orphan Products Development (OPD)

Key facts

Study ID

NCT02118727

Run by

University of Kansas Medical Center

People needed

89

Starts

2018-11-07

Expected to finish

2021-07-22

Last updated by the study team

2022-11-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-85
• Male or Female
• Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial criteria
• ALSFRS-R > 25
• Must be willing to undergo longitudinal blood draws for biomarker analysis
• Availability and willingness to complete the study
• Capable of providing informed consent and complying with trial procedures
• 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.

You may not qualify if…

• Patients with forced vital capacity (FVC) ≤ 60%
• History of liver disease
• Severe renal failure
• History of intolerance to memantine
• Onset of weakness for greater than 3 years
• Any other co-morbid condition which would make completion of the trial unlikely
• If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
• Taking any investigational medications. If the patient was previously on investigational medications, a 30-day washout period is required before the baseline visit. Non-trial medications are not cause for exclusion.
• Unwillingness to provide consent
• Remote Inclusion Criteria:
• Age 18-85
• Male or Female
• Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial criteria
• ALSFRS-R > 25
• Must be willing to undergo longitudinal blood draws for biomarker analysis. This may be foregone during the screening visit
• Availability and willingness to complete the study
• Capable of providing informed consent and complying with trial procedures
• 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
• Documentation of not clinically significant liver enzymes within the previous 6 months
• Remote Exclusion Criteria:
• Patients with FVC ≤ 60%*
• History of liver disease
• Severe renal failure
• History of intolerance to memantine
• Onset of weakness for greater than 3 years

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States
• UC Irvine — Irvine, California, United States
• University of Florida — Jacksonville, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kansas School of Medicine - Wichita — Wichita, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Missouri — Columbia, Missouri, United States
• CoxHealth — Springfield, Missouri, United States
• Providence Health Sciences — Portland, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Austin Neuromuscular Center — Austin, Texas, United States
• Nerve & Muscle Center of Texas — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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