Copaxone

Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Carcinoma in Situ + 1 more

Treatment

1 FDA approval

20 Active Studies for Copaxone

What is Copaxone

Glatiramer

The Generic name of this drug

Treatment Summary

Glatiramer acetate is a medication used to lower the frequency of relapses in people with relapsing-remitting multiple sclerosis. It is made up of four natural amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. Its average molecular weight is 5,000-9,000 daltons. Glatiramer acetate works by changing the way the immune system responds to certain conditions.

Copaxone

is the brand name

image of different drug pills on a surface

Copaxone Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Copaxone

Glatiramer

2002

9

Approved as Treatment by the FDA

Glatiramer, otherwise known as Copaxone, is approved by the FDA for 1 uses such as Multiple Sclerosis .

Multiple Sclerosis

Helps manage Multiple Sclerosis

Effectiveness

How Copaxone Affects Patients

Glatiramer acetate is a mix of four amino acids (L-glutamic acid, L-alanine, L-tyrosine, and L-lysine) used to treat relapsing multiple sclerosis. Studies have shown that it can lower the number of annualized relapse rates compared to placebo and IFNb-1a. Some patients (roughly 16%) may experience side effects such as chest pain, injection site issues, or hepatic injury. Since it modifies the immune system, it may also interfere with immune function.

How Copaxone works in the body

The exact way that glatiramer acetate works is unknown, but it likely helps to treat multiple sclerosis (MS) by altering how the immune system works. MS is caused by damage to the myelin layer that surrounds nerves. Glatiramer acetate may bind to molecules on antigen-presenting cells that would otherwise cause inflammation. It also shifts the immune system from pro-inflammatory to anti-inflammatory and may promote the production of T-regulatory cells that help suppress MS.

When to interrupt dosage

The advised dosage of Copaxone is dependent upon the identified sickness. The measure fluctuates depending on the method of delivery (e.g. Solution - Subcutaneous or Injection, solution - Subcutaneous) pointed out in the table beneath.

Condition

Dosage

Administration

Multiple Sclerosis

20.0 mg, , 20.0 mg/mL, 40.0 mg/mL

, Subcutaneous, Powder, for solution - Subcutaneous, Powder, for solution, Solution, Solution - Subcutaneous, Injection, solution - Subcutaneous, Injection, solution, Injection, Injection - Subcutaneous

Carcinoma in Situ

20.0 mg, , 20.0 mg/mL, 40.0 mg/mL

, Subcutaneous, Powder, for solution - Subcutaneous, Powder, for solution, Solution, Solution - Subcutaneous, Injection, solution - Subcutaneous, Injection, solution, Injection, Injection - Subcutaneous

Relapsing Remitting Multiple Sclerosis

20.0 mg, , 20.0 mg/mL, 40.0 mg/mL

, Subcutaneous, Powder, for solution - Subcutaneous, Powder, for solution, Solution, Solution - Subcutaneous, Injection, solution - Subcutaneous, Injection, solution, Injection, Injection - Subcutaneous

Multiple Sclerosis

20.0 mg, , 20.0 mg/mL, 40.0 mg/mL

, Subcutaneous, Powder, for solution - Subcutaneous, Powder, for solution, Solution, Solution - Subcutaneous, Injection, solution - Subcutaneous, Injection, solution, Injection, Injection - Subcutaneous

Warnings

Copaxone Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Glatiramer may interact with Pulse Frequency

Severe Hypersensitivity Reactions

Do Not Combine

Glatiramer may interact with Pulse Frequency

There are 20 known major drug interactions with Copaxone.

Common Copaxone Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Glatiramer is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abetimus

Major

The risk or severity of adverse effects can be increased when Glatiramer is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Glatiramer is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Glatiramer is combined with Antilymphocyte immunoglobulin (horse).

Apremilast

Major

The risk or severity of adverse effects can be increased when Glatiramer is combined with Apremilast.

Copaxone Toxicity & Overdose Risk

Mice and rats given 15 times the recommended human dose of glatiramer acetate did not show an increase in cancer. Laboratory studies suggest that this drug does not cause mutations. Studies in animals have not revealed any negative effects on reproduction or development. If a person takes too much glatiramer acetate, they may experience severe side effects such as liver damage, loss of fatty tissues, or skin death near the injection site. If an overdose occurs, medical attention and supportive care are recommended.

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Copaxone Novel Uses: Which Conditions Have a Clinical Trial Featuring Copaxone?

193 active clinical trials are presently assessing the therapeutic potential of Copaxone in treating Multiple Sclerosis.

Condition

Clinical Trials

Trial Phases

Multiple Sclerosis

127 Actively Recruiting

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

Carcinoma in Situ

3 Actively Recruiting

Not Applicable, Phase 4

Multiple Sclerosis

0 Actively Recruiting

Relapsing Remitting Multiple Sclerosis

14 Actively Recruiting

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

Copaxone Reviews: What are patients saying about Copaxone?

5

Patient Review

8/15/2015

Copaxone for Relapsing Form of Multiple Sclerosis

I was initially diagnosed in 1997 and have been on Avonex for 14 years. My new neurologist switched me to Copaxone, which I've found to be just as effective. I tolerate the injections well, with only minor pain at the injection site.

5

Patient Review

4/11/2018

Copaxone for Relapsing Form of Multiple Sclerosis

I've been taking this medication for a week now, and I'm hoping to see more effects soon. So far, the side effect of slurred speech has made me look drunk at work and my bosses are starting to question me.

5

Patient Review

5/26/2014

Copaxone for Multiple Sclerosis Symptoms Return then Become Less Severe

I'm really liking this treatment so far.

5

Patient Review

6/29/2016

Copaxone for Relapsing Form of Multiple Sclerosis

I had to stop taking Copaxone for a pregnancy last year, and when my doctor recommended I start back up on the 40mg dose, I was really disappointed. The side effects were awful - bruising, lumps, stinging, etc. Shared Solutions is going to help with my copay, which is awesome because it's such an expensive drug.

4

Patient Review

5/8/2014

Copaxone for Multiple Sclerosis Symptoms Return then Become Less Severe

I can only tell that this medication is working when I have my annual MRIs. From what I understand, Copaxone treats the disease but not the symptoms. However, I have seen an increase in my symptoms over the past two years while taking this drug.

3.7

Patient Review

4/23/2014

Copaxone for Multiple Sclerosis Symptoms Return then Become Less Severe

The injection process is easy enough, but I experienced swelling and itching afterwards that felt like a bee sting. This would last up to two hours. Additionally, the swelling itself could last for 48 hours. After a few weeks of use, I developed mucous colitis which caused severe back and hip pain as well as flu-like symptoms.

3.7

Patient Review

1/26/2016

Copaxone for Multiple Sclerosis Symptoms Return then Become Less Severe

Itching and uncomfortable knot in area of injection for 2 days afterwards. Worsening depression.

2

Patient Review

1/17/2014

Copaxone for Multiple Sclerosis Symptoms Return then Become Less Severe

1

Patient Review

1/31/2019

Copaxone for Relapsing Form of Multiple Sclerosis

I used to take this medication for my MS, but after a few years of use I went into anaphylactic shock. Please be aware that chest pain and other reactions are not normal side effects, no matter what you're told.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about copaxone

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

How long can you stay on Copaxone?

"Copaxone is a long-term treatment that should be taken for as long as it is effective in reducing relapses for people with MS. The percentage of people who are relapse-free after two years is 34 to 56%."

Answered by AI

What are the side effects of Copaxone?

"-Reactions at the injection site may include: pain, itching, swelling, redness, discoloration, or lumps in the place where you have the injection. You may also experience flushing (temporary warmth, redness, or deepening of skin color), rash, shortness of breath, or chest pain."

Answered by AI

What type of drug is Copaxone?

"This medication is used to treat the symptoms of Multiple sclerosis. It may be either used by itself or in conjunction with other medications. It belongs to a class of drugs referred to as Immunomodulators; Multiple Sclerosis Treatments."

Answered by AI

Is Copaxone a good MS drug?

"Copaxone has been shown to be a moderately effective treatment for Duchenne muscular dystrophy in clinical trials, reducing the number of relapses by 30% compared to those taking placebos. Additionally, MRI scans of those taking Copaxone showed fewer new areas of active MS, or none at all."

Answered by AI

What does Copaxone actually do?

"An injectable drug called Glatiramer acetate, or Copaxone, is used to treat relapsing forms of multiple sclerosis in adults. This man-made version of a protein is similar to one found in myelin, which is an insulating layer that protects many of the nerves in your body. Copaxone blocks T cells that could potentially damage the myelin."

Answered by AI

What kind of drug is Copaxone?

"Copaxone is a prescription medicine that is used to treat the symptoms of Multiple sclerosis. It may be used alone or with other medications. Copaxone belongs to a class of drugs called Immunomodulators. It is not known if it is safe and effective to use in children."

Answered by AI

Clinical Trials for Copaxone

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Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis

18 - 65
All Sexes
Calgary, Canada

Canada has one of the highest rates of multiple sclerosis (MS). MS patients experience disabling motor, visual, and sensory symptoms, and a high risk of comorbid major depressive disorder (MDD) and severe fatigue. The lifetime prevalence of MDD in MS patients is about 50%, and nearly 90% experience severe fatigue, both of which are not responsive to typical treatments. Repetitive transcranial magnetic stimulation (rTMS) is a first line, Health Canada approved non-invasive neurostimulation treatment for MDD. rTMS induces electrical activity in the cortex using magnetic fields generated outside of the head to drive neuronal firing in the target site. However, MS is typically an exclusion criterion due to safety concerns. The goal of this clinical trial is to learn if repeated transcranial magnetic stimulation (rTMS) can be used to treat depression symptoms in adults with multiple sclerosis (MS). rTMS is a non-invasive form of brain stimulation that uses magnetic pulses to stimulate specific parts of the brain. The main questions it aims to answer are: Is rTMS safe, tolerable, and feasible to deliver as a treatment for depression and fatigue symptoms in individuals with MS? Does rTMS show preliminary effectiveness in improving depression and fatigue symptoms in this population? Researchers will determine whether rTMS treatment improves mood, fatigue, and cognition across time points (baseline, after treatment, and 4-week follow-up). Participants will: Complete screening, questionnaires, clinical assessments, cognitive tests, a brain MRI to help tailor the TMS treatment, and receive daily TMS sessions for 5 consecutive days, including: Pre-TMS brain mapping, five rTMS treatments (3 minutes) per day, separated by one hour. A safety and tolerability questionnaire will be administered daily. Complete post-treatment assessments (questionnaires, cognitive tests, psychiatric evaluation). Complete a 4-week follow-up visit, in person or virtually. Wear a fitness tracking watch during the study so researchers can collect activity data remotely. About 20 people will take part in this study through the University of Calgary.

Phase 1
Waitlist Available

Foothills Medical Centre

Adrianna Giuffre, PhD.

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Treatment for Multiple Sclerosis

18+
All Sexes
Fairfield, CT

This study compared two educational methods. Participants were assigned to participate in a 360-degree experience or a slideshow presentation. The 360-degree video group included a brain and MS program. The comparison group was given a slideshow presentation with the same information. Participants viewed the 360-degree program or the slideshow presentation only once. The online-based materials consisted of a demographic form (age, gender, race and ethnicity, and name of school), knowledge questionnaires, and an experiential learning scale. Pre-intervention, participants were asked about demographic information, whether they had previous experience with MS, the science classes they completed in high school and college, and their knowledge of the human brain and MS pathophysiology. At both pre- and post-intervention, participants completed the Multiple Sclerosis Magnetic Resonance Imaging Knowledge Questionnaire (MSMRIKQ) and the Multiple Sclerosis Knowledge Questionnaire (MSKQ). At post-intervention, participants completed a lesson experiential questionnaire about their experience viewing either the 360-degree video or the slideshow presentation. Permission to use the three instruments was obtained from their respective copyright holders.

Waitlist Available
Has No Placebo

Fairfield Univesity Nursing School (+1 Sites)

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Hyperpolarized Carbon Imaging for Multiple Sclerosis

18+
All Sexes
San Francisco, CA

The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression. This method of imaging utilizes the Warburg effect, where innate immune cells utilize a metabolic shift to glycolysis instead of oxidative phosphorylation. In pre-clinical data, increased hyperpolarized lactate production has been found to be associated with increased microglial/macrophage infiltration in the brain. Although hyperpolarized carbon imaging in humans has been established and used in the field of oncology, this will be one of the first applications of hyperpolarized carbon the study of neuroinflammation in humans. We predict that hyperpolarized carbon imaging may have the potential to monitor and evaluate neuroinflammation in MS, and in particular the innate immune activation state that plays a role in MS progression. This imaging method may provide non-invasive monitoring of disease progression and therapy response for MS patients.

Phase 2
Waitlist Available

Byers Hall

Ari Green, MD

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Functional Electrical Stimulation for Stroke

18 - 80
All Sexes
Pomona, CA

People with neurological conditions often have difficulty walking, including problems such as foot drop. Functional electrical stimulation (FES) is a treatment that uses electrical signals to activate muscles and support walking. The L300 device is designed to help lift the foot during each step. This study will evaluate how using the L300 affects walking performance. Researchers will measure walking speed, step length, and walking symmetry using objective gait assessment tools. The study will also explore whether people with different neurological conditions respond differently to FES. The goal of this research is to improve understanding of how FES influences walking and to support more personalized rehabilitation approaches.

Waitlist Available
Has No Placebo

Casa Colina Hospital and Centers for Healthcare

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TRX319 + Bendamustine for Multiple Sclerosis

18 - 65
All Sexes
Kansas City, KS

The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS. The main questions the trial aims to answer are the following: * Is TRX319 safe when administered to patients with progressive forms of MS? * At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS? * Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and/or secondary progressive MS? Participants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.

Phase 1 & 2
Recruiting

University of Kansas Medical Center (+1 Sites)

Tr1X, Inc.

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Time Restricted Eating for Multiple Sclerosis

18 - 64
All Sexes
Birmingham, AL

The goal of this clinical trial is to learn if the time an individual eats each day impacts neurological health in people with multiple sclerosis. The main questions the investigators are asking are: 1. Does meal timing affect biomarkers of neuronal health (neurofilament light chain \[NfL\] and BDNF) and inflammation (IL-6, IL-17, TNF-ɑ) in adults with MS. 2. Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS. Participants will be instructed to start and stop eating at specific times each day based on their group assignment and their personal schedule. They will respond to prompts sent to them on their smartphone to record the times they start and stop eating each day. As a secondary goal, the study will also explore the feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS. To accomplish this, imaging will be completed in a subset of 8 participants at the beginning and end of the study.

Waitlist Available
Has No Placebo

University of Alabama at Birmingham

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MRI Contrast for Multiple Sclerosis

18 - 65
All Sexes
Los Angeles, CA

Multiple sclerosis (MS) is a common disease of the central nervous system that affects almost 1 million people in the United States. However, diagnosing MS can be difficult and often leads to misdiagnosis. More sensitive and specific biomarkers are needed to help with the diagnosis, prognosis, and evaluation of treatment response for MS. The central vein sign (CVS) and the paramagnetic rim lesion (PRL) are two biomarkers that have shown promise in improving diagnostic accuracy for MS. The goal of this study is to provide pilot information on the long-term performance of the CVS and PRL to help diagnose and follow people with MS. The study will follow 40 participants over 48 months to determine if the CVS and PRL help make a diagnosis of MS and how they can be used to follow people with MS. The study will also examine how PRL and CVS change over 48 months. The results of this pilot study will inform the development of a grant application to extend 5-year follow-up for all 420 participants of the CAVS-MS study. The study will use high-resolution T2\*-weighted MRI to detect the CVS and PRLs. An MRI of the brain with contrast will be used to examine CVS, PRL and longitudinal analysis of lesions that slowly grow over time (slowly expanding lesions \[SELs\]). The results of this study have the potential to improve the accuracy of diagnosing and treating MS.

Recruiting
Has No Placebo

Cedars-Sinai Medical Center (+2 Sites)

Pascal Sati, PHD

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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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