Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

June 21, 2025 updated by: Alexandre Chan, University of California, Irvine

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of cancer survivors with cancer related cognitive impairment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 1-877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Chao Family Comprehensive Cancer Center, University of California Irvine
        • Contact:
          • Alexandre Chan, PharmD, MPH
          • Phone Number: 877-827-8839
          • Email: ucstudy@uci.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female and male patients diagnosed with one of the following:

    1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions
    2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years
    3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years
  • Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.
  • ≥18 years of age
  • Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
  • Able to provide informed consent.
  • Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
  • Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

Exclusion Criteria:

  • Presence of brain metastasis
  • Unwilling to undergo neuropsychological assessments necessary for the study.

  • Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.

    a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.

  • History of suspected hypersensitivity to riluzole or to any of its excipients.
  • Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
  • Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
  • Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Riluzole
Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks
Drug: Riluzole
Given PO
Other Names:
  • RILUTEK
Placebo Comparator: Placebo
Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks
Drug: Placebo
Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)
Time Frame: 8 weeks
Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function Scores (FACT-Cog)
Time Frame: 8 weeks
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.
8 weeks
Cognitive Function Scores (CANTAB)
Time Frame: 8 weeks
The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Alexandre Chan, PharmD, MPH, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4994
  • UCI 24-05 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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