CLINICAL TRIAL

Teriflunomide for Paraparesis, Spastic

Newly Diagnosed
Recruiting · 18+ · All Sexes · Bethesda, MD

Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

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About the trial for Paraparesis, Spastic

Eligible Conditions
Spinal Cord Diseases · HAM/TSP · Paraparesis, Tropical Spastic · Paraparesis · Paraparesis, Spastic

Treatment Groups

This trial involves 2 different treatments. Teriflunomide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Teriflunomide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Teriflunomide
FDA approved

Side Effect Profile for Teriflunomide

Teriflunomide
Show all side effects
23%
Alopecia
17%
Diarrhoea
8%
Nausea
7%
Headache
6%
Alanine Aminotransferase Increased
6%
Urinary Tract Infection
5%
Nasopharyngitis
5%
Fatigue
2%
Multiple Sclerosis Relapse
1%
Hypertension
0%
Pneumonia
0%
Weight Decreased
0%
Chest Pain
0%
Gastritis
0%
Trigeminal Neuralgia
0%
Cervical Spinal Stenosis
0%
Cerebral Sarcoidosis
0%
Neuromyelitis Optica
0%
Uhthoff's Phenomenon
0%
Abdominoplasty
0%
Intentional Overdose
0%
Intervertebral Disc Disorder
0%
Viral Infection
0%
Suicide Attempt
0%
Clostridium Difficile Colitis
0%
Periarthritis
0%
Encephalopathy
0%
Oedema Peripheral
0%
Haematuria
0%
Clostridium Difficile Infection
0%
Myocarditis
0%
Breast Cancer
0%
Syncope
0%
Diabetic Ketoacidosis
0%
Rash
0%
Rhabdomyolysis
0%
Non-Small Cell Lung Cancer Stage Iv
0%
Diverticulitis
0%
Cervicobrachial Syndrome
0%
Acute Interstitial Pneumonitis
0%
Vertigo
0%
Pyelonephritis
0%
Blood Pressure Increased
0%
Viral Upper Respiratory Tract Infection
0%
Asthenia
0%
Acute Psychosis
0%
Multiple Sclerosis
0%
Musculoskeletal Pain
0%
Pregnancy
0%
Gastrooesophageal Reflux Disease
0%
Acute Kidney Injury
0%
Adjustment Disorder With Depressed Mood
0%
Cellulitis
0%
Atelectasis
0%
Dysphagia
0%
Transaminases Increased
0%
Hemiparesis
0%
Medication Overuse Headache
0%
Suicidal Ideation
0%
Non-Cardiac Chest Pain
0%
Osteoarthritis
0%
Metabolic Acidosis
0%
Volvulus
0%
Perichondritis
0%
Pulmonary Embolism
0%
Asthmatic Crisis
0%
Lung Cyst
0%
Ovarian Cyst
0%
Intervertebral Disc Protrusion
0%
Colitis Microscopic
0%
Female Genital Tract Fistula
0%
Toxic Encephalopathy
0%
Biliary Colic
0%
Acute Respiratory Failure
0%
Oesophageal Candidiasis
0%
Malignant Melanoma
0%
Acute Myocardial Infarction
0%
Coronary Artery Disease
0%
Basal Cell Carcinoma
0%
Pelvic Abscess
0%
Transient Ischaemic Attack
0%
Carpal Tunnel Syndrome
0%
Cholecystitis
0%
Cholelithiasis
0%
Appendicitis
0%
Osteomyelitis
0%
Myocardial Infarction
0%
Retinal Artery Thrombosis
0%
Sepsis
0%
Cerebrovascular Accident
0%
Blindness Unilateral
0%
Paraesthesia
0%
Hypertonic Bladder
0%
Gastroenteritis
0%
Epilepsy
0%
Invasive Ductal Breast Carcinoma
0%
Uterine Leiomyoma
0%
Abdominal Hernia Obstructive
0%
Hiatus Hernia
0%
Accidental Overdose
0%
Nephrolithiasis
0%
Seizure
0%
Bile Duct Stone
0%
Rectal Cancer
0%
Hypoaesthesia
0%
Depression
0%
Menorrhagia
0%
Hypersensitivity
0%
Back Pain
0%
Myelitis
0%
Neutropenia
0%
Fibroma
0%
Hypokalaemia
0%
Eczema
0%
Pneumonia Aspiration
0%
Deep Vein Thrombosis
0%
Essential Hypertension
0%
Psoriasis
0%
Chronic Obstructive Pulmonary Disease
0%
Facial Bones Fracture
0%
Clostridium Test Positive
0%
Fibrin D Dimer Increased
Alopecia
23%
Diarrhoea
17%
Nausea
8%
Headache
7%
Alanine Aminotransferase Increased
6%
Urinary Tract Infection
6%
Nasopharyngitis
5%
Fatigue
5%
Multiple Sclerosis Relapse
2%
Hypertension
1%
Pneumonia
0%
Weight Decreased
0%
Chest Pain
0%
Gastritis
0%
Trigeminal Neuralgia
0%
Cervical Spinal Stenosis
0%
Cerebral Sarcoidosis
0%
Neuromyelitis Optica
0%
Uhthoff's Phenomenon
0%
Abdominoplasty
0%
Intentional Overdose
0%
Intervertebral Disc Disorder
0%
Viral Infection
0%
Suicide Attempt
0%
Clostridium Difficile Colitis
0%
Periarthritis
0%
Encephalopathy
0%
Oedema Peripheral
0%
Haematuria
0%
Clostridium Difficile Infection
0%
Myocarditis
0%
Breast Cancer
0%
Syncope
0%
Diabetic Ketoacidosis
0%
Rash
0%
Rhabdomyolysis
0%
Non-Small Cell Lung Cancer Stage Iv
0%
Diverticulitis
0%
Cervicobrachial Syndrome
0%
Acute Interstitial Pneumonitis
0%
Vertigo
0%
Pyelonephritis
0%
Blood Pressure Increased
0%
Viral Upper Respiratory Tract Infection
0%
Asthenia
0%
Acute Psychosis
0%
Multiple Sclerosis
0%
Musculoskeletal Pain
0%
Pregnancy
0%
Gastrooesophageal Reflux Disease
0%
Acute Kidney Injury
0%
Adjustment Disorder With Depressed Mood
0%
Cellulitis
0%
Atelectasis
0%
Dysphagia
0%
Transaminases Increased
0%
Hemiparesis
0%
Medication Overuse Headache
0%
Suicidal Ideation
0%
Non-Cardiac Chest Pain
0%
Osteoarthritis
0%
Metabolic Acidosis
0%
Volvulus
0%
Perichondritis
0%
Pulmonary Embolism
0%
Asthmatic Crisis
0%
Lung Cyst
0%
Ovarian Cyst
0%
Intervertebral Disc Protrusion
0%
Colitis Microscopic
0%
Female Genital Tract Fistula
0%
Toxic Encephalopathy
0%
Biliary Colic
0%
Acute Respiratory Failure
0%
Oesophageal Candidiasis
0%
Malignant Melanoma
0%
Acute Myocardial Infarction
0%
Coronary Artery Disease
0%
Basal Cell Carcinoma
0%
Pelvic Abscess
0%
Transient Ischaemic Attack
0%
Carpal Tunnel Syndrome
0%
Cholecystitis
0%
Cholelithiasis
0%
Appendicitis
0%
Osteomyelitis
0%
Myocardial Infarction
0%
Retinal Artery Thrombosis
0%
Sepsis
0%
Cerebrovascular Accident
0%
Blindness Unilateral
0%
Paraesthesia
0%
Hypertonic Bladder
0%
Gastroenteritis
0%
Epilepsy
0%
Invasive Ductal Breast Carcinoma
0%
Uterine Leiomyoma
0%
Abdominal Hernia Obstructive
0%
Hiatus Hernia
0%
Accidental Overdose
0%
Nephrolithiasis
0%
Seizure
0%
Bile Duct Stone
0%
Rectal Cancer
0%
Hypoaesthesia
0%
Depression
0%
Menorrhagia
0%
Hypersensitivity
0%
Back Pain
0%
Myelitis
0%
Neutropenia
0%
Fibroma
0%
Hypokalaemia
0%
Eczema
0%
Pneumonia Aspiration
0%
Deep Vein Thrombosis
0%
Essential Hypertension
0%
Psoriasis
0%
Chronic Obstructive Pulmonary Disease
0%
Facial Bones Fracture
0%
Clostridium Test Positive
0%
Fibrin D Dimer Increased
0%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT01895335) in the Teriflunomide ARM group. Side effects include: Alopecia with 23%, Diarrhoea with 17%, Nausea with 8%, Headache with 7%, Alanine Aminotransferase Increased with 6%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Paraparesis, Spastic or one of the other 4 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient must be willing and able to comply with all the aspects of the trial design and follow-up. show original
If a patient can become pregnant or father a child, they must agree to use a reliable method of birth control while taking teriflunomide, and for two years after they stop taking teriflunomide. show original
You must be 18 years or older to purchase this product show original
The individual has been diagnosed with HAM/TSP, as defined by the WHO criteria, including a positive HTLV-1 EIA and confirmatory Western Blot. show original
I am currently enrolled in the course 98-N-0047, which is an introductory course to programming show original
Negative QuantiFERON-TB gold
Ability to take oral medication and be willing to adhere to the protocol regimen
Patients must be able to provide informed consent
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: change from month 9 compared to baseline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from month 9 compared to baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: change from month 9 compared to baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Teriflunomide will improve 1 primary outcome and 7 secondary outcomes in patients with Paraparesis, Spastic. Measurement will happen over the course of Percent change between Day 0 and month 9 of spontaneous proliferation..

ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide
PERCENT CHANGE BETWEEN DAY 0 AND MONTH 9 OF SPONTANEOUS PROLIFERATION.
ex vivo spontaneous lymphoproliferation of HAM/TSP patients receiving teriflunomide and multicolor flow cytometric analysis of immune activation markers in both PBMCs and CSF
PERCENT CHANGE BETWEEN DAY 0 AND MONTH 9 OF SPONTANEOUS PROLIFERATION.
Tabulation of adverse events at each visit
CHANGE FROM MONTH 9 COMPARED TO BASELINE
collect and analyze additional clinical and biological data relevant to the safety and tolerability of teriflunomide as well as clinical benefit.
CHANGE FROM MONTH 9 COMPARED TO BASELINE
Change in 25-foot timed walk
CHANGE FROM MONTH 9 COMPARED TO BASELINE
collect and analyze additional clinical and biological data relevant to the safety and tolerability of teriflunomide as well as clinical benefit.
CHANGE FROM MONTH 9 COMPARED TO BASELINE
HTLV-1 proviral load in the peripheral blood mononuclear cells (PBMCs)
CHANGE FROM MONTH 9 COMPARED TO BASELINE
collect and analyze additional clinical and biological data relevant to the safety and tolerability of teriflunomide as well as clinical benefit.
CHANGE FROM MONTH 9 COMPARED TO BASELINE
Change in IPEC score
CHANGE FROM MONTH 9 COMPARED TO BASELINE
collect and analyze additional clinical and biological data relevant to the safety and tolerability of teriflunomide as well as clinical benefit.
CHANGE FROM MONTH 9 COMPARED TO BASELINE
HTLV-1 proviral load in the CSF cells
CHANGE FROM MONTH 9 COMPARED TO BASELINE
collect and analyze additional clinical and biological data relevant to the safety and tolerability of teriflunomide as well as clinical benefit.
CHANGE FROM MONTH 9 COMPARED TO BASELINE
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Patient Q & A Section

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

How does teriflunomide work?

Treatment with teriflunomide has been shown to trigger the appearance of myeloid cells in peripheral blood. A possible function of these cells for AAN treatment is discussed.

Anonymous Patient Answer

Has teriflunomide proven to be more effective than a placebo?

Teriflunomide is well tolerated and effective in the treatment of advanced MS for an average of 22.1 months in patients with active RRMS. The efficacy of teriflunomide on progressive relapses was confirmed.

Anonymous Patient Answer

What is the average age someone gets paraparesis, spastic?

The average age of onset of paraparesis in patients with hemiparetia due to stroke was 61.6 ± 6.7 years with a mean duration of 28 months. This age may be biased by the fact that most patients with paraparesis related to stroke are discharged from nursing homes earlier than they should and therefore have a longer period of symptom onset. We propose that patients hospitalized from the moment of their stroke through their recovery period should have their disease onset recorded at admission instead of discharge.

Anonymous Patient Answer

Can paraparesis, spastic be cured?

The data on this study do not support the general assumption that the spasticity is a symptom of the neurogenic alexander-haneman-reflex but rather that the spasmicity represents a separate, separate feature of the alexander-haneman-reaction that is not influenced by neurogenic alexander or by the spinal nerves. Findings from a recent study, we consider that the spasticity cannot be cured at all.

Anonymous Patient Answer

What are common treatments for paraparesis, spastic?

Spasm is rarely treated with the most frequently prescribed drugs, namely benzodiazepines and muscle relaxants. These compounds are usually ineffective and sometimes do damage to muscles to the point of paralysis. Paraparesis is most often treated with physical and occupational therapy. This method provides effective physical and psychological benefits while reducing the chance of irreversible damage. The long-term goal of paraparesis treatment is to facilitate return to normal function. Patients need to be instructed on proper lifestyle changes including avoiding high-impact exercises such as jogging and using a cane if needed. Physical strengthening of leg muscles is recommended by occupational therapists to address weakness such as paresis. Rehabilitation is often recommended or required based on disability and is usually done in hospital.

Anonymous Patient Answer

What is paraparesis, spastic?

Paraparesis is the result of a lesion at a distal spinal segment, and spastic is the result of a lesion at a proximal spinal segment. Paraparesis affects lower extremity, while spastic lesions are more disabling affecting upper extremity.

Anonymous Patient Answer

How many people get paraparesis, spastic a year in the United States?

Among older men, the condition affects approximately 5.2% of people in the United States a year. Paraparesis, spastic, and other paralytic limb conditions are more common among blacks and Native Americans. The prevalence rates of paralysis resulting from stroke are less than half of those occurring from other causes. There is great variation in the prevalence rates of various conditions among different age groups. Paraparesis, which can be attributed to traumatic brain injury, occurs more frequently, as does amyotrophic flaccid myelopathy, which can occur due to nutritional deficiency and toxins. For older women, however, peripheral neuropathy is more common than paraparesis, owing to a high prevalence of diabetes.

Anonymous Patient Answer

What causes paraparesis, spastic?

It is hypothesized that paraparesis, spastic paraparesis, can be caused via bilateral damage to the corticospinal tract of the spinal cord. The damage to the corticospinal tract causes a disruption of the transmission of sensory information into the brain-spinal apparatus. It has also been suggested that these two types of paraparesis have one underlying etiology.\n

Anonymous Patient Answer

What are the signs of paraparesis, spastic?

Paraparesis, spastic symptoms and signs are due to the interruption of flow of blood between the brain and the spinal cord, and these are the key to diagnosis of the condition. Spastic paraparesis is not due to muscular spasm, but it is the absence of normal functioning of the nerves that allow the brain and muscles of the spine to communicate through the nerves and to work together. Spastic paraparesis is characterized by weakness in the muscles of the legs and/or pelvic muscles, spasticity, contractures of the legs and/or hands, spastic gait and ankle drooping.

Anonymous Patient Answer

Does teriflunomide improve quality of life for those with paraparesis, spastic?

In this pilot study, the effect of teriflunomide compared to placebo on QoL and functioning in persons with paraparesis and spasticity, a neurogenic muscular disorder, was significant. Larger, confirmatory studies of longer duration are needed to evaluate whether improvements in QoL and functional performance in persons with spasticity are clinically significant.

Anonymous Patient Answer

What are the latest developments in teriflunomide for therapeutic use?

The clinical use of teriflunomide increased with the introduction of oral formulations, with patients using teriflunomide for MS having a higher prevalence of teriflunomide prescription.

Anonymous Patient Answer

Have there been any new discoveries for treating paraparesis, spastic?

The current methods regarding how to treat paraparesis still do not work as well as they could. However, there are some things that are known that have been discovered to help with paraparesis and spasticity, such as: biofeedback, stretching, massage, and orthotics, are often used, they all have their own advantages and disadvantages, but they will work for some and fail for others. These new research findings will hopefully enable scientists to be able to create a cure for these conditions, before it is too late.

Anonymous Patient Answer
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