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

NCT06580002 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 4994UCI 24-05
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Sarcoma; Gastric Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)

  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 Outcomes (2)

• Cognitive Function Scores (FACT-Cog)

  8 weeks

• Cognitive Function Scores (CANTAB)

  8 weeks

Study Arms (2)

Riluzole

EXPERIMENTAL

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

Drug: Riluzole

Placebo

PLACEBO COMPARATOR

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

Interventions

Riluzole DRUG

Given PO

Also known as: RILUTEK

Riluzole

Placebo DRUG

Given PO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients diagnosed with one of the following:
• Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions
• Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Sarcoma; Stomach Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Liver Neoplasms; Urogenital Neoplasms

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Liver Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alexandre Chan, PharmD, MPH

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

US (1)