UnknownPhase 4

A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets

United States30 participantsStarted 2020-09-16

Plain-language summary

The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.

Who can participate

Age range21 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female between 21 and 65 years old, inclusive.
✓. Must be capable of understanding and providing written informed consent, including subject authorization under the health insurance portability and accountability act (HIPPA), prior to any study related procedures that are not part of routine medical care.
✓. Has an EDSS score at the screening visit of 2.0 to 7.0 inclusive.
✓. Have a diagnosis of clinically definite SPMS. (Lublin, 2014)
✓. Are considered neurologically stable for \> 30 days prior to both screening, baseline and week 48.
✓. Must be otherwise healthy without confounding diseases.
✓. Subject has decided to pursue cladribine tablets as their disease modifying therapy (DMT) of choice, and have signed a study specific informed consent form.
✓. Must be willing and physically able to comply with all required protocol visits and complete all assessments.

Exclusion criteria

✕. Subjects with a diagnosis of a sub-type of MS other than PMS active (clinically definite SPMS)
✕. Have MRI findings other than MS that are considered significant per the P.I.
✕. Have a clinical condition or medical history noted as a contraindication as per the FDA/US package insert guidelines.
✕. Have a history of chronic disease(s) of the immune system, other than MS or a known immunodeficiency syndrome.
✕. Have comorbid conditions that preclude participation, including any condition that might increase brain biomarkers such as traumatic brain injury (TBI), meningitis, stroke, or drug abuse in the last 12 months or any other medical condition deemed significant for increased biomarkers by the investigator.
✕. Have an active/acute infection (bacterial, viral, fungal, etc.) at the time of screen AND/OR baseline or within 4 weeks prior to or at the start of course 2 year 2 that would interfere with the safety of the study.
✕. Have a current or past significant history of poorly controlled diabetes mellitus, obesity (BMI over 35) or anorexia (BMI under 18), hypertension or hyperlipidemia as determined by the investigator.
✕. Have a history or presence of malignancy other than basal cell epithelioma (BCE) or cervical cancer in-situ following a complete excision. Cancer that has been absent for more than 10 years and considered to be cured is allowed.

What they're measuring

Time to achieve no evidence of disease activity (NEDA) -4 compared to baseline

Timeframe: 96 weeks

Decrease of serum/CSF NfL

Timeframe: 48 weeks

Trial details

NCT IDNCT04550455

SponsorKeith Edwards, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Judy Button

518-785-1000 jbutton@tristateneuro.com

View on ClinicalTrials.gov More Multiple Sclerosis trials