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

Study Purpose

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 breast cancer survivors with cancer related cognitive impairment.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Female and male patients diagnosed with breast cancer.

- Past exposure to chemotherapy, radiotherapy, surgery and/or other breast cancer interventions.

There is no minimum treatment time to be considered eligible.

- Washout of 30 days from investigational interventions is required if the patient was previously treated in a research study.

There is no washout required from placebo investigational interventions. Washout for conventional interventions is up to the discretion of the Investigator, if the conventional intervention is not planned to be concurrently administered with riluzole/placebo.

- ≥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 still 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06580002
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Irvine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexandre Chan, PharmD, MPH
Principal Investigator Affiliation	Chao Family Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer

Arms & Interventions

Arms

Experimental: Riluzole

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks

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

Interventions

Drug: - Riluzole

Given PO

Drug: - Placebo

Given PO

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orange, California

Status

Recruiting

Address

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868

Site Contact

Alexandre Chan, PharmD, MPH

[email protected]

877-827-8839

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