Glatiramer Acetate

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

Treatment

1 FDA approval

20 Active Studies for Glatiramer Acetate

What is Glatiramer Acetate

Glatiramer

The Generic name of this drug

Treatment Summary

Glatiramer acetate is an immunomodulating drug made from a combination of four amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. It is commonly used to reduce the frequency of relapses in multiple sclerosis patients. The average molecular weight of glatiramer acetate is between 5,000 and 9,000 daltons.

Copaxone

is the brand name

image of different drug pills on a surface

Glatiramer Acetate 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 Glatiramer Acetate Affects Patients

Glatiramer acetate is a combination of four natural amino acids that is used to treat multiple sclerosis. Studies have shown that it can help reduce relapse rates. Some patients have experienced reactions after injection, such as chest pain, injection site side effects, and liver problems. Taking glatiramer acetate may also interfere with immune function.

How Glatiramer Acetate works in the body

Glatiramer Acetate works to treat Multiple Sclerosis by altering the immune system. It stops certain cells from releasing inflammatory chemicals, and encourages other cells to produce anti-inflammatory chemicals. It also works to bind to molecules that stop the body from attacking its own nerve cells, and can create regulatory cells that help suppress MS.

When to interrupt dosage

The suggested measure of Glatiramer Acetate is contingent upon the recognized disorder. The degree of dosage deviates, as per the technique of delivery (e.g. Solution - Subcutaneous or Injection, solution - Subcutaneous) featured 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

Glatiramer Acetate 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 Glatiramer Acetate.

Common Glatiramer Acetate 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.

Glatiramer Acetate Toxicity & Overdose Risk

In mice and rats given 15 times the typical dosage of glatiramer acetate, there was no increased risk of cancer or mutations. No negative effects on reproduction or development were seen. It is not known what effects an overdose could have, but potential side effects include liver damage, loss of fat under the skin, and skin death at the injection site. If an overdose occurs, it is recommended to provide supportive treatment.

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Glatiramer Acetate Novel Uses: Which Conditions Have a Clinical Trial Featuring Glatiramer Acetate?

193 clinical trials are currently underway to assess the potential of Glatiramer Acetate to ameliorate 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

Glatiramer Acetate Reviews: What are patients saying about Glatiramer Acetate?

5

Patient Review

3/5/2008

Glatiramer Acetate for Multiple Sclerosis Symptoms Return then Become Less Severe

I was diagnosed with MS 15 years ago and have been on Copaxone for six. Recently, I had an MRI that showed no new lesions in my brain--in fact, the hospital couldn't even locate some of my previous ones. The best advice I can give is to stay committed to a treatment, exercise, maintain a positive internal attitude, and develop a close relationship with God. The only downside to this drug is the cost.

4.7

Patient Review

11/30/2007

Glatiramer Acetate for Multiple Sclerosis Symptoms Return then Become Less Severe

Used this until my insurance ran out. It was $1780 per month.

4.3

Patient Review

3/28/2009

Glatiramer Acetate for Multiple Sclerosis Symptoms Return then Become Less Severe

I initially began treatment with interferon, but found the side effects becoming unmanageable. My husband then noticed that I was displaying signs of depression, so my doctor took me off the medication and started me on copaxone instead. I haven't experienced any negative side effects from this drug, and actually find the injections easier to handle than before (even though I have to do them more often).

4

Patient Review

3/31/2009

Glatiramer Acetate for Multiple Sclerosis Symptoms Return then Become Less Severe

I don't love having to take a shot every day, but it's definitely preferable to the deep tissue shots. I was taking Avonex before, but the side effects were really bad (to the point of causing depression and mood swings). This medication is much better in that regard, even though it does give me some pretty intense headaches.

3

Patient Review

11/21/2018

Glatiramer Acetate for Relapsing Form of Multiple Sclerosis

I haven't received the medication yet, so I can't really rate it. I'm just giving it a middle-of-the-road score for now. Fingers crossed that it helps.
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Patient Q&A Section about glatiramer acetate

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

Is glatiramer acetate an immunosuppressant?

"GA is a man-made protein that is similar to myelin basic protein, a protein in the myelin sheath that surrounds and protects nerve cells in the central nervous system.

Glatiramer acetate is a drug that is used to treat multiple sclerosis. It is a man-made protein that is similar to myelin basic protein, which is a protein that is found in the myelin sheath."

Answered by AI

How long does glatiramer acetate take to work?

"If you are taking COPAXONE®, you may see some results within 12 months. Relapsing MS most commonly affects the central nervous system (CNS). The CNS is made up of the brain, spinal cord, and optic nerves. The immune system causes the CNS to respond abnormally."

Answered by AI

What class of drug is glatiramer acetate?

"Glatiramer is a type of immunomodulator that works by preventing the body from damaging its own nerve cells."

Answered by AI

What is glatiramer acetate used for?

"An immunomodulating drug called glatiramer acetate is used to treat multiple sclerosis. It is made of a copolymer of amino acid residues that are in the same proportions as in myelin basic protein."

Answered by AI

Clinical Trials for Glatiramer Acetate

Image of Foothills Medical Centre in Calgary, Canada.

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

Image of University of Kansas Medical Center in Kansas City, United States.

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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