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Immunomodulator

Fingolimod for Peripheral Neuropathy

Phase < 1
Waitlist Available
Led By Charles L Loprinzi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
Tingling, numbness or pain was at least a four out of ten problem during the week prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem (patient verbal report to clinician)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months post treatment
Awards & highlights

Study Summary

This trial is testing whether fingolimod can reduce chemotherapy-induced nerve pain. Fingolimod suppresses immune reactions in the brain, so the study is to see if it can reduce neuropathy.

Eligible Conditions
  • Peripheral Neuropathy
  • Numbness
  • Pain
  • Paresthesia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing pain or symptoms of a condition called CIPN (Chemotherapy-Induced Peripheral Neuropathy) for at least 3 months and you want treatment for it.
Select...
You have experienced significant tingling, numbness, or pain rated at least four out of ten in the past week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serially measured total sensory neuropathy scores
Secondary outcome measures
Incidence of adverse events (AEs) of fingolimod

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Fingolimod)Experimental Treatment3 Interventions
Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks. Take your Fingolimod approximately every 24 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fingolimod
2012
Completed Phase 4
~11330
Fingolimod Hydrochloride
2019
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,782 Total Patients Enrolled
6 Trials studying Peripheral Neuropathy
354 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,151 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Charles L LoprinziPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Fingolimod (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT03943498 — Phase < 1
Peripheral Neuropathy Research Study Groups: Treatment (Fingolimod)
Peripheral Neuropathy Clinical Trial 2023: Fingolimod Highlights & Side Effects. Trial Name: NCT03943498 — Phase < 1
Fingolimod (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03943498 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy
2019. "Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03943498.
~0 spots leftby Apr 2025
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