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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
Be older than 18 years old
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 3 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months post treatment
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
3,234 Previous Clinical Trials
3,771,845 Total Patients Enrolled
6 Trials studying Peripheral Neuropathy
354 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,440 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used or are currently using fingolimod medication.You have had a heart attack, unstable chest pain, stroke, or mini-stroke in the past six months. You have also been hospitalized for severe heart failure or have had significant heart failure symptoms in the past six months.You have a heart condition called Mobitz type II second degree or third degree atrioventricular (AV) block or sick sinus syndrome, unless you have a pacemaker.You have had an allergic reaction to fingolimod or any of its ingredients, which caused symptoms like a rash, hives, or swelling.You are currently taking a specific type of medication for heart rhythm problems called class Ia or III antiarrhythmic drugs.You are taking medications that weaken your immune system.You have a weakened immune system, which can include having HIV.You have a family history of a nerve disorder that is passed down through genes.You are currently taking medications like duloxetine, gabapentin, or pregabalin to treat nerve pain, and you are not willing to stop taking them before starting the study.You have been diagnosed with diabetic or other peripheral neuropathy in the past.You have a history of nerve damage before receiving chemotherapy that can cause nerve problems.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.You have experienced significant tingling, numbness, or pain rated at least four out of ten in the past week.You have a history of certain health conditions like heart disease, high blood pressure, or diabetes.You are currently taking beta blockers, calcium channel blockers, or digoxin for another medical condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Fingolimod)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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