CLINICAL TRIAL

Mavenclad® for Multiple Sclerosis

1 Prior Treatment
Relapsed
Recruiting · 18+ · All Sexes · Klagenfurt, Austria

This study is evaluating whether a drug called Mavenclad can help people with multiple sclerosis.

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About the trial for Multiple Sclerosis

Eligible Conditions
Multiple Sclerosis · Sclerosis

Treatment Groups

This trial involves 2 different treatments. Mavenclad® 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Mavenclad®
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
Cladribine
FDA approved

Side Effect Profile for Experimental: Mavenclad®

Experimental: Mavenclad®
Show all side effects
26%
Headache
14%
Nasopharyngitis
8%
Nausea
8%
Fatigue
7%
Diarrhoea
6%
Urinary tract infection
6%
Alopecia
1%
Cerebrovascular accident
0%
Papillary thyroid cancer
0%
Left ventricular dysfunction
0%
Diplopia
0%
Eye haemorrhage
0%
Vestibular neuronitis
0%
Eye pain
0%
Gastritis
0%
Carotid endarterectomy
0%
Dizziness
Headache
26%
Nasopharyngitis
14%
Nausea
8%
Fatigue
8%
Diarrhoea
7%
Urinary tract infection
6%
Alopecia
6%
Cerebrovascular accident
1%
Papillary thyroid cancer
0%
Left ventricular dysfunction
0%
Diplopia
0%
Eye haemorrhage
0%
Vestibular neuronitis
0%
Eye pain
0%
Gastritis
0%
Carotid endarterectomy
0%
Dizziness
0%
This histogram enumerates side effects from a completed 2022 Phase 4 trial (NCT03364036) in the Experimental: Mavenclad® ARM group. Side effects include: Headache with 26%, Nasopharyngitis with 14%, Nausea with 8%, Fatigue with 8%, Diarrhoea with 7%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Sclerosis or the other condition listed above. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Individuals who took part in the MAGNIFY trial and received a dose of cladribine tablets had their MRI data collected at 18 or 24 months, as well as information on their Expanded Disability Status Scale (EDSS) and relapse rates at 24 months. show original
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.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: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
Screening: ~3 weeks
Treatment: Varies
Reporting: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study.
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 Mavenclad® will improve 1 primary outcome and 18 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of Time from Baseline (extension study), up to 2 years.

Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
Time from Extension Study Baseline to Second Qualifying Relapse
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
Time from Extension Study Baseline to First New or Enlarging T2 Lesion
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs)
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
Time from Extension Study Baseline to First Qualifying Relapse
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS)
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
TIME FROM BASELINE (EXTENSION STUDY), UP TO 2 YEARS
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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 many people get multiple sclerosis a year in the United States?

Nearly 4,300 people were diagnosed with MS in 2017. It is estimated that about 100,000 new cases of MS will be registered with the CDC in year 2020.

Anonymous Patient Answer

What is multiple sclerosis?

Despite the fact that several of the symptoms of MS are quite common in other diseases, we believe that MS presents a unique diagnostic challenge because it is an illness in which all symptoms are present in an atypical manner. Although in practice there is a tremendous diagnostic and therapeutic opportunity as the number of patients diagnosed with MS increases, clinicians cannot know at presentation what the most appropriate disease diagnosis is. Therefore, we have developed a diagnostic diagnostic triad of MS using well established diagnostic techniques that will allow prompt and efficient differentiation between the most commonly occurring MS-like syndromes.

Anonymous Patient Answer

What are the signs of multiple sclerosis?

In MS patients, the clinical course of the condition is variable. This variability is mainly explained by the presence or absence of lesions. The most frequent signs of MS are fatigue, dyspnoea, tremor, spasticity, and loss of sensation (loss of the tingling sensation). Most of these signs tend to occur concomitantly. Anosmia is also a common feature and is present in about 50–75% of MS patients at different stages of the disease.

Anonymous Patient Answer

What causes multiple sclerosis?

There is no single cause for MS; thus, current hypotheses need to be revised. It is not clear if both genes and environmental factors play a significant role in the development of MS. The role of genetic and environmental factors varies by ethnic group and in different areas within the global population.

Anonymous Patient Answer

Can multiple sclerosis be cured?

Although multiple sclerosis can be highly disabling, it is easily and completely curable with medication or immunomodulatory therapies. However, this does not mean that the disease cannot cause any permanent damage to the nervous system or that it is an incurable disease.

Anonymous Patient Answer

What are common treatments for multiple sclerosis?

In MS, the first line of treatment is typically with nonsteroidal anti-inflammatory drugs, such as ibuprofen. Steroid injections may be used to prevent flares from recurring. Other options may include cognitive behavioral therapy, physical therapy, or acupuncture. In MS, the first line of treatment tends to be different from MS diagnosis to diagnosis.\n

Anonymous Patient Answer

Does mavenclad® improve quality of life for those with multiple sclerosis?

Mavenclad® significantly reduced most of the Quality of Life Questionnaire subscale score parameters in a cohort of patients with multiple sclerosis, with no significant difference in quality of life parameters when comparing before and after administration of Mavenclad®.

Anonymous Patient Answer

Who should consider clinical trials for multiple sclerosis?

Few patients with MS are interested in clinical trials and the willingness to undertake treatment in this setting is higher when treating other conditions: for this reason, our results could be biased by selection bias.

Anonymous Patient Answer

What are the common side effects of mavenclad®?

The side effects of mavenclad® are mainly injection site reactions like local pruritus and pain or inflammation at the injection site, fatigue, a burning cough, headaches, dizziness, nausea, vomiting, fever, muscle pains, shortness of breath, difficulty in breathing, and vomiting. Side effects can generally be avoided by administering the correct dose in the right setting and by staying on time, as the injection of VAREN will always be the same once the auto self injection takes effect - once in the arm.

Anonymous Patient Answer

How does mavenclad® work?

A formulation that delivers the biologically active moiety to the cells, when taken daily, can lead to a clinically significant reduction in MS Disease Activity Expanded (SPEL, or Seddon Score, or MRI Remission). This finding has been confirmed in other placebo-controlled, Phase I clinical trials. The most plausible mechanism of action may be through the inhibition of NF-κB mediated nuclear translocation, and down regulation of genes related with inflammation, like VCAM-1"

"Conus ritchiei\n\nConus ritchiei is an extinct species of sea snail, a marine gastropod mollusk in the family Conidae, the cone snails and their allies.

Anonymous Patient Answer

What is the latest research for multiple sclerosis?

All of the studies reported are still preliminary, but the results of this paper support a better understanding of the pathogenesis of MS lesions. The use of microRNAs is now an active area of research for all neurologic disorders, including MS. The role of these small molecules, in neuronal signalling, has also recently been tested in MS. Although more studies are needed, the current evidence suggests that miRNAs may be effective in controlling the progression of MS and that their pharmacological modulation may be a promising strategy for MS treatment in the near future.

Anonymous Patient Answer

Has mavenclad® proven to be more effective than a placebo?

A 6-week placebo-controlled trial in 40 patients with moderate to severe relapsing remitting multiple sclerosis assessed that Mavenclad® was significantly more effective than a placebo for improving the severity of relapsing-remitting disease activity\n\nThe US FDA had originally approved Apotransfusion's intravenous form of Ampyra, but Apotransfusion voluntarily halted further marketing of Ampyra in the US market. The FDA later approved Ampyra as an autoinfusion under a different brand name (Ampyra) and approved an intranasal formulation of Ampyra the following year.

Anonymous Patient Answer
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