Phase 2
Completed N=89
Therapy in Amyotrophic Lateral Sclerosis (TAME)
Amyotrophic Lateral Sclerosis · Frontal Temporal Dementia
Source: ClinicalTrials.gov NCT02118727 ↗
Enrolled (actual)
89
Serious AEs
12.4%
Results posted
Nov 2022
Primary outcomePrimary: The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks. — -0.290; -0.281 score on a scale/week
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks. |
-0.290; -0.281 | — |
Eligibility Criteria
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
- 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.
Exclusion Criteria
- 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
- 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
- Since FVC cannot be captured during a remote screening visit, and acceptable FVC performed within the previous 90 days is acceptable. If an FVC is not available within the previous 90 days, the subject may be enrolled if the local site PI believes the subject has no significant shortness of breath or respiratory issues.
Data sourced from ClinicalTrials.gov (NCT02118727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.