CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Riluzole +1 moredrug
Likely dose
Riluzole 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02796755
NCT02796755Phase 4Completed

Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation

Emory University·interventional·Posted Jun 13, 2016·Updated Apr 14, 2021

In Brief

A Phase 4 clinical trial evaluating Riluzole and Placebo for Inflammation and Fatigue. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 13, 2016
Enrollment StartApr 1, 2016
Primary CompletionOct 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.1 years ago

Interventions

Riluzoledrug

Study participants randomized to this arm will take 100 mg/day of riluzole for 8 weeks.

Placebodrug

Study participants randomized to this arm will take a placebo, that matches the appearance of 100 mg tablets of riluzole, daily for 8 weeks.