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NCT02118727 · ClinicalTrials.gov registry record · Phase 2
Therapy in Amyotrophic Lateral Sclerosis (TAME)
A Phase 2 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT02118727: Completed Phase 2 study, sponsored by University of Kansas Medical Center.
NCT02118727 is a Phase 2 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118727, a Phase 2 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study 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)
Primary Outcome
The primary outcome measure will be disease progression as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) during the 36 weeks of therapy. The patient's rate of progression on active therapy during the 36 week treatment arm will be compared to the rate of progression of the placebo arm. The ALSFRS-R is a 12 question rating scale used to determine each participant's assessment of their capability and independence in daily activities. Possible values are
Interventions
- DRUG Memantine
- DRUG Placebo (for Memantine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 2 |
What the finished NCT02118727 record still lists
NCT02118727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Memantine is the first listed.
NCT02118727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02118727 about?
NCT02118727 is a clinical study titled "Therapy in Amyotrophic Lateral Sclerosis (TAME)". 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 bo...
What is the current status of trial NCT02118727?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2018-11-07. Estimated completion is 2021-07-22.
What interventions are being tested in trial NCT02118727?
The interventions under investigation include: Memantine (DRUG), Placebo (for Memantine) (DRUG).
Who is sponsoring clinical trial NCT02118727?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02118727's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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