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NCT02781454 · ClinicalTrials.gov registry record · Phase 2
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02781454: Completed Phase 2 study, sponsored by University of Washington.
NCT02781454 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02781454, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. The investigators will also determine if there are any signs that the drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This will be determined through transcranial magnetic stimulation (TMS) and threshold tracking nerve conduction studies (TTNCS). In this trial, the participants will be taking either 300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).
Primary Outcome
The resting motor threshold (RMT) assessed from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, was used as the primary pharmacodynamic marker of cortical hyperexcitability. RMT is the stimulus intensity required to produce and maintain a 0.2 mV peak-to-peak motor evoked potential of the abductor pollicis brevis muscle by TMS. A smaller RMT is thought to suggest greater neuronal excitabili
Interventions
- DRUG Placebo
- DRUG Mexiletine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-10 |
| Est. Completion | 2018-09-30 |
| Phase | Phase 2 |
What the finished NCT02781454 record still lists
NCT02781454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02781454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02781454 about?
NCT02781454 is a clinical study titled "Mexiletine in Sporadic Amyotrophic Lateral Sclerosis". The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. The investigators will also determine if there are any signs that the drug may slow down the progressi...
What is the current status of trial NCT02781454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2016-10. Estimated completion is 2018-09-30.
What interventions are being tested in trial NCT02781454?
The interventions under investigation include: Placebo (DRUG), Mexiletine (DRUG).
Who is sponsoring clinical trial NCT02781454?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02781454's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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