Fingolimod Hydrochloride

Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Carcinoma in Situ + 2 more

Treatment

20 Active Studies for Fingolimod Hydrochloride

What is Fingolimod Hydrochloride

Fingolimod

The Generic name of this drug

Treatment Summary

Fingolimod is a medication used to treat Multiple Sclerosis (MS), a chronic inflammatory disorder that can cause physical, cognitive, and neurological impairments. It was created by Novartis and approved by the FDA in 2010. It is currently being tested to see if it can help treat COVID-19, the disease caused by SARS-CoV-2 virus, with Phase 2 clinical trials expected to be completed in July 2020.

Gilenya

is the brand name

image of different drug pills on a surface

Fingolimod Hydrochloride Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Gilenya

Fingolimod

2010

16

Effectiveness

How Fingolimod Hydrochloride Affects Patients

Fingolimod is used to treat multiple sclerosis, and may also help reduce lung inflammation in people with COVID-19. However, taking it may cause a decrease in heart rate and prolong the QT interval.

How Fingolimod Hydrochloride works in the body

Fingolimod is a drug that helps regulate inflammation in people with Multiple Sclerosis (MS). It works by binding to certain receptors in the body, including the cardiovascular, immune, and central nervous systems. When bound, it stops lymphocytes from leaving the lymph nodes and entering the circulation. This reduces the inflammation associated with MS. It's also sometimes used to prevent Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19.

When to interrupt dosage

The measure of Fingolimod Hydrochloride is contingent upon the diagnosed ailment, including Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS) and Alternative Treatment. The magnitude of dosage is contingent upon the method of administration (e.g. Capsule - Oral or Capsule) presented in the table below.

Condition

Dosage

Administration

Relapsing Remitting Multiple Sclerosis

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Carcinoma in Situ

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Multiple Sclerosis

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Multiple Sclerosis

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Alternative Treatment

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Warnings

Fingolimod Hydrochloride has fifteen contraindications, so its use should be avoided in circumstances involving any of the conditions in the following table.

Fingolimod Hydrochloride Contraindications

Condition

Risk Level

Notes

Atrioventricular Block

Do Not Combine

Atrioventricular Block

Do Not Combine

Stroke

Do Not Combine

Angina, Unstable

Do Not Combine

Transient Ischemic Attack (TIA)

Do Not Combine

Atrioventricular Block

Do Not Combine

Heart Decompensation

Do Not Combine

Sick Sinus Syndrome

Do Not Combine

Heart failure

Do Not Combine

Pulse Frequency

Do Not Combine

Atrioventricular Block

Do Not Combine

Pulse Frequency

Do Not Combine

Heart Attack

Do Not Combine

Pulse Frequency

Do Not Combine

Heart failure

Do Not Combine

There are 20 known major drug interactions with Fingolimod Hydrochloride.

Common Fingolimod Hydrochloride Drug Interactions

Drug Name

Risk Level

Description

Adenovirus type 7 vaccine live

Major

The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Fingolimod.

Ajmaline

Major

Fingolimod may increase the arrhythmogenic activities of Ajmaline.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Fingolimod.

Amiodarone

Major

Fingolimod may increase the arrhythmogenic activities of Amiodarone.

Anthrax vaccine

Major

The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Fingolimod.

Fingolimod Hydrochloride Toxicity & Overdose Risk

The lowest toxic dose of fingolimod in rats is between 300 - 600 mg/kg. In one case report, an intentional overdose of 14mg of fingolimod and 2g of phenoxymethylpenicillin caused low blood pressure and a slow heartbeat, both of which were reversed by taking atropine. As fingolimod has been linked to heart problems, it is likely that an overdose could cause similar issues such as a slow heartbeat and blockage of the heart's electrical signals.

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Fingolimod Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Fingolimod Hydrochloride?

At present, 44 active studies are being conducted to assess the effectiveness of Fingolimod Hydrochloride in treating active Secondary Progressive Multiple Sclerosis (SPMS), Multiple Sclerosis and Carcinoma in Situ.

Condition

Clinical Trials

Trial Phases

Multiple Sclerosis

12 Actively Recruiting

Phase 3, Phase 4, Phase 2

Relapsing Remitting Multiple Sclerosis

14 Actively Recruiting

Not Applicable, Phase 3, Phase 2, Phase 4, Early Phase 1

Alternative Treatment

0 Actively Recruiting

Carcinoma in Situ

3 Actively Recruiting

Not Applicable, Phase 4

Multiple Sclerosis

0 Actively Recruiting

Fingolimod Hydrochloride Reviews: What are patients saying about Fingolimod Hydrochloride?

5

Patient Review

6/17/2012

Fingolimod Hydrochloride for Multiple Sclerosis Symptoms Return then Become Less Severe

This treatment has been wonderful. I'm unable to take any other treatments, so this really was a blessing. In the two years that I've been taking it, I've only had one flare-up compared to six to ten per year previously. Additionally, I haven't felt this good in a long time.

5

Patient Review

12/21/2010

Fingolimod Hydrochloride for Multiple Sclerosis Symptoms Return then Become Less Severe

I've been in a clinical trial for this medicine for 3+ years and it's going great! I've had mild side effects and excellent results. No new MS attacks in over 3 years.
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Patient Q&A Section about fingolimod hydrochloride

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is fingolimod used for MS?

"Fingolimod is an immunotherapeutic drug that is used to target the sphingosine-1-phosphate receptor. It is a widely used medication for relapsing-remitting multiple sclerosis (MS)."

Answered by AI

What is fingolimod used for?

"Fingolimod is used to help manage relapsing-remitting forms of multiple sclerosis (where symptoms flare up from time to time) in adults and children 10 years and older. It may help prevent episodes of symptoms and slow the progression of disability caused by MS."

Answered by AI

What is the brand name for fingolimod?

"Gilenya is a prescription medicine that is used to treat the symptoms of Multiple sclerosis. It is an immunomodulator and sphingosine 1-phosphate receptor modulator that can be used alone or with other medications."

Answered by AI

What is the mechanism of action of fingolimod?

"Fingolimod works by binding to and activating the S1P1 receptor, which is found on the surface of lymphocytes. This prevents the lymphocytes from leaving the lymph nodes, and reduces the amount of autoaggressive lymphocytes that can enter the central nervous system."

Answered by AI

Clinical Trials for Fingolimod Hydrochloride

Image of University of Illinois at Chicago in Chicago, United States.

Functional Balance Intervention for Multiple Sclerosis

40 - 90
All Sexes
Chicago, IL

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

Recruiting
Has No Placebo

University of Illinois at Chicago

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CYB704 vs Ocrevus for Multiple Sclerosis

18 - 55
All Sexes
Maitland, FL

The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will: * Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU) * Visit the clinic for at least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

Phase 3
Recruiting

Sandoz Investigational Site (+1 Sites)

Sandoz

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Vagus Nerve Stimulation for Multiple Sclerosis

18 - 65
All Sexes
Aurora, CO

The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are: * Is stimulating the vagus nerve safe and feasible after demyelinating episodes? * Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis? Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control. Participants will: * Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months. * During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test. * At various timepoints in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.

Recruiting
1 Prior Treatment

Clinical Translational Research Center at CU Anschutz

Jeffrey Bennett, MD

Image of Georgia State University in Atlanta, United States.

Ublituximab for Multiple Sclerosis

18 - 55
All Sexes
Atlanta, GA

The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.

Phase < 1
Waitlist Available

Georgia State University (+1 Sites)

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Intermittent Hypoxia for Multiple Sclerosis

18 - 75
All Sexes
Chicago, IL

This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.

Recruiting
Has No Placebo

Shirley Ryan AbilityLab

Milap Sandhu, Pt, PhD

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