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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06580002
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 30, 2024
Start date
Dec 2, 2024
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California IrvineOrangeCalifornia92868
Alexandre Chan, PharmD, MPH
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center, University of California Irvine· Orange, CA

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