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Anti-metabolites
Cladribine Tablets for Multiple Sclerosis
Phase 4
Recruiting
Research Sponsored by Keith Edwards, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female between 21 and 65 years old, inclusive
Have a diagnosis of clinically definite SPMS. (Lublin, 2014)
Must not have
History of or current renal Impairment that is considered moderate to severe. (creatinine clearance below 50 mL per minute)
Have a contraindication to a lumbar puncture. (i.e. abnormal coagulation panel, skin infection at the location of Lumbar Puncture (LP), increased cranial pressure, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will test if a biomarker can be used to detect activity in Multiple Sclerosis and if it can be used to adjust treatment to prevent dysfunction.
Who is the study for?
This trial is for adults aged 21-65 with clinically definite Secondary Progressive Multiple Sclerosis (SPMS) who are neurologically stable and have chosen Cladribine Tablets as their treatment. Participants must be healthy otherwise, not pregnant or breastfeeding, agree to use effective contraception, and commit to follow-ups for two years post-study.
What is being tested?
The study tests if biomarkers can detect MS activity in patients taking Cladribine Tablets, potentially guiding treatment changes to prevent dysfunction. It involves routine clinic visits and assessments over a two-year period following FDA guidelines.
What are the potential side effects?
Potential side effects of Cladribine Tablets include risks of birth defects (teratogenicity), reduced white blood cell count (lymphopenia), other blood disorders, increased risk of infections, liver injury, allergic reactions (hypersensitivity), and heart failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
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I have been diagnosed with secondary progressive multiple sclerosis.
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I have chosen cladribine tablets as my treatment and signed the consent form.
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My disability score is between 2.0 and 7.0.
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I am between 21 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is moderately to severely impaired.
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I cannot have a lumbar puncture due to health risks.
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I don't have any health conditions that the FDA says should not be treated with this drug.
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I have or had severe diabetes, obesity, anorexia, high blood pressure, or high cholesterol.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study and for 6 months after.
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I have a type of multiple sclerosis that is not primary progressive.
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I have never been treated with cladribine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decrease of serum/CSF NfL
Time to achieve no evidence of disease activity (NEDA) -4 compared to baseline
Secondary study objectives
Change in Cognitive Function
Change in upper body function
Other study objectives
CSF/serum NfL antibody as markers for progressive multiple sclerosis (PMS)
CSF/serum glial fibrillary acidic protein (GFAP)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cladribine TabletsExperimental Treatment1 Intervention
All participants will receive cladribine tablets according to the current United States Federal Food and Drug Administration (FDA) package guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine Tablets
2019
N/A
~110
Find a Location
Who is running the clinical trial?
Keith Edwards, M.D.Lead Sponsor
EMD SeronoIndustry Sponsor
145 Previous Clinical Trials
27,749 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,255 Patients Enrolled for Multiple Sclerosis
Keith R Edwards, M.D.Study DirectorMS Center of Northeastern New York, P.C.
3 Previous Clinical Trials
129 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
99 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 65 years old.I have a liver condition or history of heavy drinking.My neurological condition has been stable for more than 30 days.I am generally healthy with no major illnesses.I do not have conditions like TBI, meningitis, stroke, or recent drug abuse that could affect brain tests.My kidney function is moderately to severely impaired.I cannot have a lumbar puncture due to health risks.I don't have any health conditions that the FDA says should not be treated with this drug.I am willing and able to follow all study requirements.I have or had severe diabetes, obesity, anorexia, high blood pressure, or high cholesterol.I do not have any current infections that could affect my safety in the study.I have no cancer history except for treated BCE or cervical cancer, or any cancer cured over 10 years ago.I have been diagnosed with secondary progressive multiple sclerosis.I have chosen cladribine tablets as my treatment and signed the consent form.I am not pregnant, planning to become pregnant, or breastfeeding during the study and for 6 months after.My lymphocyte count is below 800 cells/µL before starting the second treatment.I am willing to attend clinic visits for 2 years after the study ends.I am willing and able to follow all study requirements.I have a type of multiple sclerosis that is not primary progressive.I am willing to use contraception for 6 months after my last dose of the study medication.My partner might get pregnant during the study or within 6 months after I stop taking cladribine tablets.I am willing to attend clinic visits for 2 years after the study ends.I have never been treated with cladribine.My disability score is between 2.0 and 7.0.I have read and understand the risks related to the treatment as outlined by the FDA.I have read and understand the risks related to my treatment, including effects on pregnancy, blood counts, infections, liver, allergies, heart issues, and how to manage my medication.I am not pregnant or breastfeeding, not trying to conceive, and will use effective birth control during and 6 months after the study.My neurological condition has been stable for over a month.I am between 21 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cladribine Tablets
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT04550455 — Phase 4
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