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NCT03500289 · ClinicalTrials.gov registry record · Phase 1
Ketamine for Treatment of MS Fatigue
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03500289: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT03500289 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03500289, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Multiple sclerosis (MS) is an inflammatory, demyelinating and degenerative disease of the central nervous system and, after trauma, is the most common cause of disability in young adults, affecting more than 400,000 individuals in the US. Of all the symptoms that can occur with MS, chronic fatigue is the most common and disabling, reported by at least 75% of patients at some point. Fatigue limits patients' daily activities, and challenges employment, resulting in substantial socioeconomic consequences. Despite this negative impact, fatigue treatments have been inconsistently studied, in part due to poorly understood underlying pathophysiological mechanisms. Yet to be defined biological processes and lack of clear treatment targets have also hampered the development of drugs for fatigue. As a result, there are no medications approved by the Food and Drug Administration (FDA) for the treatment of MS fatigue. The investigators recently reported that riluzole, a medication with anti-glutamatergic effects, increased the fatigue severity in patients with relapsing MS who had participated in a clinical trial evaluating potential neuroprotective effects of riluzole versus placebo. Three other clinic trials which examined memantine effects on cognition in patient with MS also reported worsening fatigue as a major side effect. Memantine main mechanism of action is blocking the N-methyl D-aspartate (NMDA) glutamate receptor. These observations prompted the investigators that glutamatergic transmission probably plays an important role in fatigue pathogenesis and modulating these pathways could have potential therapeutic effect on MS-related fatigue. A recent paper reported that ketamine, an NMDA receptor blocker with different kinetics compared to memantine, had a strong and prolonged effect in reducing fatigue in bipolar patients who participated in a clinical trial, evaluating anti-depressive effects of ketamine versus placebo. Interestingly, the effect of ketamine on fatigu
Interventions
- DRUG Ketamine
- DRUG Midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-10 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03500289
The ClinicalTrials.gov registry entry for NCT03500289 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT03500289 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03500289 about?
NCT03500289 is a clinical study titled "Ketamine for Treatment of MS Fatigue". Multiple sclerosis (MS) is an inflammatory, demyelinating and degenerative disease of the central nervous system and, after trauma, is the most common cause of disability in young adults, affecting more than 400,000 individuals in the US. Of all the symptoms that can occur with MS, chronic fatigue i...
What is the current status of trial NCT03500289?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-08-10. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT03500289?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG).
Who is sponsoring clinical trial NCT03500289?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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