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NCT02796755 · ClinicalTrials.gov registry record · Phase 4
Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02796755 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 30 participants.
The verdict
NCT02796755, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of the proposed research is to determine whether riluzole, a drug that increases glutamate reuptake, will decrease central nervous system (CNS) glutamate in breast cancer survivors with increased inflammation and fatigue. The researchers will also determine whether decreasing glutamate with riluzole will reverse inflammation-related fatigue and other symptoms including cognitive dysfunction and decreased motivation. To accomplish these goals, the researchers plan to conduct an 8 week, double-blind, randomized control trial of riluzole (100 mg/d) versus placebo in 40 breast cancer survivors (n=20 per group). All breast cancer survivors will have completed treatment within 1-3 years and have a fatigue level of ≥4 (on a 10 point scale) and a plasma c-reactive protein (CRP) concentration \>3mg/L (indicative of high inflammation). Participants will undergo magnetic resonance spectroscopy (MRS) to measure CNS glutamate before and after 2 and 8 weeks of riluzole or placebo treatment. Fatigue and other behavioral assessments including measures of cognitive function and motivation will be conducted before and after treatment and correlated with the change in CNS glutamate.
Interventions
- DRUG Placebo
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-10-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02796755
The ClinicalTrials.gov registry entry for NCT02796755 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02796755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02796755 about?
NCT02796755 is a clinical study titled "Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation". The goal of the proposed research is to determine whether riluzole, a drug that increases glutamate reuptake, will decrease central nervous system (CNS) glutamate in breast cancer survivors with increased inflammation and fatigue. The researchers will also determine whether decreasing glutamate with...
What is the current status of trial NCT02796755?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2016-04. Estimated completion is 2019-10-24.
What interventions are being tested in trial NCT02796755?
The interventions under investigation include: Placebo (DRUG), Riluzole (DRUG).
Who is sponsoring clinical trial NCT02796755?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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