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Amyotrophic Lateral Sclerosis | Therapy in Amyotrophic Lateral Sclerosis (TAME)

Amyotrophic Lateral Sclerosis research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Amyotrophic Lateral Sclerosis

Frontal Temporal Dementia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MemantineAll randomized patients will be instructed to take one tablet once a day for the first week from a blinded bottle that contains 10 mg tablets or matching placebo. At week two, patients will be instructed to take one tablet twice a day from the 10 mg bottle or matching placebo. At week three, patients will be instructed to take two tablets in the morning from the 10 mg bottle and one tablet from the 10 mg bottle or the matching placebo bottle in the evening. At week four patients will be instructed to take two pills twice a day from the 10 mg bottle or matching placebo.

Drug:Placebo (for Memantine)All randomized patients will be instructed to take one tablet once a day for the first week from a blinded bottle that contains 10 mg tablets or matching placebo. At week two, patients will be instructed to take one tablet twice a day from the 10 mg bottle or matching placebo. At week three, patients will be instructed to take two tablets in the morning from the 10 mg bottle and one tablet from the 10 mg bottle or the matching placebo bottle in the evening. At week four patients will be instructed to take two pills twice a day from the 10 mg bottle or matching placebo.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Memantine20mg taken by mouth every day BID for 32 weeks

PlaceboPlacebo (for Memantine) taken by mouth everyday BID for 32 weeks

Study Status

Recruiting

Start Date: November 7, 2018

Completed Date: October 2022

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Disease progression as measured by the number of points lost on the ALS Functional Rating-Scale-Revised (ALSFRS-R)

Secondary Outcome: Measuring the levels of Tau, pNFH and the pNFH/C3 ratio in blood

Study sponsors, principal investigator, and references

Principal Investigator: Richard D Barohn, MD

Lead Sponsor: University of Kansas Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02118727

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