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Cladribine Tablets for Multiple Sclerosis
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Cladribine Tablets
- 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.
- 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.
Frequently Asked Questions
Can septuagenarians partake in this experiment?
"This trial is open to applicants aged between 21 and 65. There are an additional 46 trials available for those below the age of consent, along with 418 clinical studies for folks over 65 years old."
What ailments is Cladribine Tablets commonly employed to treat?
"Cladribine Tablets are a viable therapy for ctage1 protein, human hairy cell leukemia and multiple sclerosis."
Is enrolment open for this experiment?
"Affirmative. Evidence on clinicaltrials.gov indicates that this medical trial, which was uploaded to the site on September 16th 2020, is actively recruiting participants. The study seeks 30 individuals from a single research centre."
Are there other investigations that have been conducted utilizing Cladribine Tablets?
"Currently, there are 34 separate clinical trials that involve Cladribine Tablets. Of those, 7 have advanced to Phase 3. Most of these tests are being conducted in Houston; however 359 other sites across the US are also running experiements on this medication."
What demographic is most suited to participate in this investigation?
"This clinical trial is enrolling a population of 30 persons with multiple sclerosis, aged between 21 and 65. In order to be admitted into the study, participants must demonstrate their ability to follow all protocol visits and assessments; understand the risks associated with teratogenicity, lactation issues, lymphopenia or other hematologic toxicity etc.; have not shown neurological changes in more than 1 month prior to screening/baseline visitations; display a healthy constitution without any confounding diseases; commit themselves to two years of routine clinic check-ups after completion of trials as per FDA guidelines; and present an EDSS score ranging from 2 - 7"
Has the FDA sanctioned Cladribine Tablets for medicinal use?
"The safety of Cladribine Tablets is rated a 3, as it has been approved for use by the FDA following extensive Phase 4 trials."
What is the aggregate number of participants in this research project?
"Affirmative. Clinicaltrials.gov records state that this experiment, which initially began recruiting in September 16th 2020, is still searching for participants. A total of 30 individuals are necessary to be recruited from one facility."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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