Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07447050
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Riluzole — DRUG
    Given PO
  • Placebo — OTHER
    Given PO

Study Details

This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.

Key Dates

Start date
Dec 23, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Riluzole
    Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months
  • 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 up to 6 months

Primary Outcome Measure

Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy [ Time Frame: 6 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California IrvineOrangeCalifornia92868-

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By specialty
OncologyBreast oncologyWomen's healthGI oncologyENTHepatologyLung oncologyLung diseaseGynecologic oncology
By research site
Chao Family Comprehensive Cancer Center, University of California Irvine· Orange, CA

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