Recruiting
Phase 2

Riluzole

Sponsor:

UCLA

Code:

NCT06580002

Conditions

Breast Cancer

Sarcoma

Gastric Cancer

Lung Cancer

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Riluzole

Placebo

Study Details

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 in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

Conditions

Breast Cancer

Sarcoma

Gastric Cancer

Lung Cancer

Head and Neck Cancer

Study ID

NCT06580002

Start date

Dec 2, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Cohort-specific inclusion for male and female patients.

a. Cohort A (no prior cranial radiation) i. 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.

b. Cohort B (prior cranial radiation)
  • Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors.
  • Life expectancy > 6 months
2. Washout from investigational and conventional 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.
3. ≥18 years of age
4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment.
5. Able to provide informed consent.
6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
7. 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:

1. Cohort-specific exclusion for male and female patients:

1. Cohort A (no prior cranial radiation)

  • History of or current presence of primary brain tumors or brain metastases.
2. Cohort B (prior cranial radiation)

  • Diagnosed with high grade glioma.
2. Unwilling to undergo neuropsychological assessments necessary for the study.
3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) 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.
4. History of suspected hypersensitivity to riluzole or to any of its excipients.
5. 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.
6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Riluzole

Given PO

Placebo

Given PO

Primary outcome measure

  • Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

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

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Alexandre Chan, PharmD, MPH

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-07-14.