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

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

Image of Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo in Buffalo, United States.

Mindset Training for MS

18 - 65
All Sexes
Buffalo, NY

People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).

Recruiting
1 Prior Treatment

Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

Hanneke E Hulst, Prof

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Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis. Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells. A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy. The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.

Phase 1 & 2
Waitlist Available

Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)

Gavin Solomon, President & CEO

Truway Health, Inc.

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Ocrelizumab for Multiple Sclerosis

18 - 75
All Sexes
Detroit, MI

This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.

Waitlist Available
Has No Placebo

John D. Dingell VA Medical Center

Genentech, Inc.

Image of Toronto Rehabilitation Institute in Toronto, Canada.

Balance Training with Electrical Stimulation for Multiple Sclerosis

18 - 65
All Sexes
Toronto, Canada

This study will evaluate the effects of combining balance training with electrical stimulation techniques in individuals with Multiple Sclerosis (MS). MS commonly impairs leg strength, coordination, and balance, increasing the risk of falls and reducing independence. The interventions include:Balance training only, Balance training with Functional Electrical Stimulation (FES), and Balance training with FES and Transcutaneous Spinal Cord Stimulation (TSCS). FES delivers small electrical pulses to leg muscles, while TSCS delivers electrical signals through the skin to stimulate the spinal cord and enhance motor control. The study will enroll up to 24 participants over a 3-year period. This trial is funded by MS Canada. Participants will be randomly assigned to one of three groups: (1) balance training only, (2) balance training with FES, or (3) balance training with FES and TSCS. All participants will complete 12 supervised training sessions over 6 weeks. During each session, participants will engage in interactive balance games while standing in a safety harness.Outcome assessments will be conducted at three time points: baseline (prior to training), post-intervention (after 6 weeks), and follow-up (8 weeks after training). Assessments will include: * Clinical tests of mobility and balance (Timed Up and Go:TUG, 10-Meter Walk Test:10MWT, Berg Balance Scale:BBS) * Computerized balance testing using a force plate * Questionnaires on walking ability, fear of falling, and balance confidence * Neurophysiological measures of brain-spinal cord-muscle communication before and after training

Waitlist Available
Senior-friendly

Toronto Rehabilitation Institute

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[F-18]FDG-PET for MS

18 - 70
All Sexes
Boston, MA

Given the need for better diagnostic imaging techniques in multiple sclerosis (MS), the study aims to investigate the utility of \[F-18\]FDG positron emission tomography (PET) in MS. The study will be assessing glucose consumption patterns in subjects with progressive MS (PMS) and relapsing-remitting MS (RRMS), as well as healthy controls. PET will be compared to magnetic resonance imaging (MRI) lesion load and brain atrophy, and serum and blood biomarkers, as well as clinical measures of physical disability, cognitive impairment, fatigue, and depression. This study's findings may pave a path for integrating \[F-18\]FDG-PET in routine clinical practice for MS, improving patient experiences and outcomes. The specific aims of the study are: Aim 1: To compare glucose consumption in the brain in subjects with PMS, relapsing-remitting MS (RRMS), and healthy controls, using the radiolabeled glucose analogue 18-fluorodeoxyglucose, also known as \[F-18\]FDG. Aim 2: To compare the relationship between FDG-PET and standard 3T MRI measures including global and regional brain atrophy and lesion load, and to compare FDG-PET with MRI in terms of their relationship with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS subjects. Aim 3: To assess the relationship of FDG-PET with serum and blood biomarkers, including but not limited to sNfL, GFAP, IL-6, and TNFα in MS.

Phase 4
Recruiting

Brigham & Women's Hospital

Tarun Singhal, MD, MBBS

Genzyme, a Sanofi Company

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