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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

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

0 / 12Eligibility criteria met