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Anti-metabolites
Cladribine for Multiple Sclerosis (CLOCK-MS Trial)
Phase 4
Waitlist Available
Led By Gregory Wu
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an EDSS of 0 to ≤ 5.5 during the screening period
Have a relapsing form of multiple sclerosis (RMS; to include RRMS or active secondary progressive MS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks, 10 weeks, 1 year, or 2 years
Awards & highlights
CLOCK-MS Trial Summary
This trial will help researchers understand how the drug Cladribine works in the bodies of people with relapsing forms of MS.
Who is the study for?
This trial is for people with relapsing forms of multiple sclerosis who can undergo lumbar punctures, have had recent MS activity, and normal lymphocyte counts. They must be able to consent and not have any contraindications for lumbar puncture, current cancer, HIV, active chronic infections like hepatitis or tuberculosis, PML signs in MRI scans, hypersensitivity to cladribine or its components.Check my eligibility
What is being tested?
The study tests the effects of Cladribine tablets on biomarkers in the central nervous system and blood that are relevant in relapsing forms of multiple sclerosis. It aims to understand how Cladribine works by monitoring changes in these biomarkers.See study design
What are the potential side effects?
Cladribine may cause side effects such as immune system suppression leading to increased infection risk; potential liver or kidney issues; allergic reactions; and possibly other unknown risks associated with altering central nervous system biomarkers.
CLOCK-MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disability level is moderate or better.
Select...
I have a type of multiple sclerosis that comes and goes.
Select...
I am willing and able to undergo at least 2 spinal taps.
Select...
My MRI shows new or worsening brain lesions in the past year.
CLOCK-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks, 10 weeks, 1 year, or 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks, 10 weeks, 1 year, or 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in the CSF levels of lymphocyte subtypes and markers of neuronal injury during treatment with cladribine tablets in patients with RMS
Side effects data
From 2011 Phase 3 trial • 867 Patients • NCT0064153724%
Back pain
20%
Neutropenia
12%
Hyperthermia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
6%
Weight decreased
6%
Hypertension
6%
Anxiety
6%
Respiratory tract infection viral
6%
Joint swelling
6%
Anaemia of pregnancy
6%
Viral upper respiratory tract infection
6%
Skin bacterial infection
6%
Dizziness
6%
Viral infection
6%
Arthralgia
6%
Sinusitis
6%
Carpal tunnel syndrome
6%
Infected insect bite
6%
Uterine leiomyoma
6%
Depressed mood
6%
Pharyngolaryngeal pain
6%
Cough
6%
Joint sprain
6%
Eye irritation
6%
Upper respiratory tract infection
6%
Headache
6%
Depression
6%
Restless legs syndrome
6%
Pain in extremity
6%
Eye pruritus
6%
Contusion
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Pregnancy
6%
Herpes zoster
6%
Liver function test abnormal
6%
Abortion threatened
6%
Iron deficiency anaemia
6%
Erythema infectiosum
6%
Tooth disorder
6%
Faecal incontinence
6%
Injection site abscess
6%
White blood cell count decreased
6%
Sensation of heaviness
6%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cladribine 3.5 mg/kg/No Treatment
Cladribine 5.25 mg/kg/No Treatment
Cladribine Low/Placebo (LLPP)
Cladribine High Dose/Placebo (HLPP)
Cladribine Low/Low Dose (LLLL)
Cladribine High/Low Dose (HLLL)
Placebo/Cladribine Low Dose (PPLL)
Placebo/No Treatment
CLOCK-MS Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 4: LP at Baseline and End of Year 2Experimental Treatment1 Intervention
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
Group II: Group 3: LP at Baseline and End of Year 1Experimental Treatment1 Intervention
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
Group III: Group 2: LP at Baseline and Week 10Experimental Treatment1 Intervention
Group 2: LP at Baseline and end of Week 10. Week 10 is the expected "nadir" time for lymphocyte and monocyte levels in CSF
Group IV: Group 1: LP at Baseline and Week 5Experimental Treatment1 Intervention
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
FDA approved
Find a Location
Who is running the clinical trial?
EMD SeronoIndustry Sponsor
143 Previous Clinical Trials
27,154 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,243 Patients Enrolled for Multiple Sclerosis
Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,678 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
52,235 Patients Enrolled for Multiple Sclerosis
Gregory WuPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disability level is moderate or better.I do not have ongoing infections like hepatitis or tuberculosis.You are allergic to gadolinium or have a condition that prevents you from getting an MRI.My MRI shows signs that might indicate a brain infection called PML.I have a type of multiple sclerosis that comes and goes.My kidneys are not working well (poor kidney function).I have not had immunosuppressive or myelosuppressive therapy in the last 6 months.I am not pregnant and can use effective birth control during and 6 months after treatment.I am HIV positive.I am currently on medication that weakens my immune system.You have had a bad reaction to cladribine or any of the ingredients in the cladribine tablets.I have been treated with cladribine before.I am willing and able to undergo at least 2 spinal taps.I have been treated with ocrelizumab, alemtuzumab, rituximab, or daclizumab.I have been treated with natalizumab in the past 6 months.I have been on steroids for the last 4 weeks.I cannot have a lumbar puncture due to health reasons.My liver is not working well (Child-Pugh score >6).I currently have cancer.My white blood cell count is normal.My MRI shows new or worsening brain lesions in the past year.I am able to understand and sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: LP at Baseline and Week 5
- Group 2: Group 3: LP at Baseline and End of Year 1
- Group 3: Group 2: LP at Baseline and Week 10
- Group 4: Group 4: LP at Baseline and End of Year 2
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling participants for this scientific exploration?
"Confirmed. According to the information held on clinicaltrials.gov, this investigation which was first advertised in October of 2019 is now open for recruitment. The study requires 50 participants from 5 distinct sites."
Answered by AI
To which medical conditions is this remedy typically administered?
"This treatment has proven effective against ctage1 protein, human hairy cell leukemia, and multiple sclerosis."
Answered by AI
Who meets the prerequisites for participation in this experiment?
"This trial is recruiting 50 individuals between 18 and 65 with acute relapsing multiple sclerosis. In addition, they must be willing and able to receive at least two lumbar punctures, have RMS or active secondary progressive MS, and an EDSS of 0 to 5.5 in the screening period."
Answered by AI
Is the eligibility for this clinical trial limited to adults above 18 years old?
"This medical trial is looking for participants aged over 18 yet underneath the age of 65."
Answered by AI
How widespread is the implementation of this research trial in hospitals?
"Presently, 5 sites are now recruiting individuals for this research project. These clinics can be found in Philadelphia, Milwaukee and Dallas as well as other locales. To reduce travel time, it is best to select the closest clinic if you plan on participating in the trial."
Answered by AI
Have any other trials been conducted to assess the effectiveness of this therapy?
"Originally researched in 2004 at a Community-based Hematological Oncology Medical Office, 33 studies have already concluded. Now 34 additional trials are being conducted and many of these initiatives are happening within Philadelphia, Pennsylvania."
Answered by AI
How many individuals are receiving therapy through this clinical research?
"Affirmative. According to information available on clinicaltrials.gov, this medical study has been actively recruiting patients since October 28th 2019 and was last updated on August 26th 2022. It is looking for 50 participants from 5 different sites."
Answered by AI
Has this remedy gained official sanction from the FDA?
"The safety of this treatment is well-established and thus has been awarded a score of 3. This Phase 4 trial confirms the approval status of said medication."
Answered by AI
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