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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)
Must not have
Have active chronic infections (e.g. hepatitis or tuberculosis)
Have signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML) in MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks, 10 weeks, 1 year, or 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level is moderate or better.
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I have a type of multiple sclerosis that comes and goes.
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I am willing and able to undergo at least 2 spinal taps.
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My MRI shows new or worsening brain lesions in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have ongoing infections like hepatitis or tuberculosis.
Select...
My MRI shows signs that might indicate a brain infection called PML.
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My kidneys are not working well (poor kidney function).
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I have not had immunosuppressive or myelosuppressive therapy in the last 6 months.
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I am HIV positive.
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I am currently on medication that weakens my immune system.
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I have been treated with cladribine before.
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I have been treated with ocrelizumab, alemtuzumab, rituximab, or daclizumab.
Select...
I cannot have a lumbar puncture due to health reasons.
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My liver is not working well (Child-Pugh score >6).
Select...
I currently have cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks, 10 weeks, 1 year, or 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks, 10 weeks, 1 year, or 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 • NCT00641537
24%
Back pain
20%
Neutropenia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
12%
Hyperthermia
6%
Depression
6%
Carpal tunnel syndrome
6%
Viral upper respiratory tract infection
6%
Uterine leiomyoma
6%
Upper respiratory tract infection
6%
Pain in extremity
6%
Headache
6%
Arthralgia
6%
Anxiety
6%
Hypertension
6%
Anaemia of pregnancy
6%
Eye irritation
6%
Eye pruritus
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Respiratory tract infection viral
6%
Viral infection
6%
Herpes zoster
6%
Sinusitis
6%
Infected insect bite
6%
Skin bacterial infection
6%
Contusion
6%
Joint sprain
6%
Liver function test abnormal
6%
Weight decreased
6%
Dizziness
6%
Joint swelling
6%
Pharyngolaryngeal pain
6%
Cough
6%
Restless legs syndrome
6%
Pregnancy
6%
Depressed mood
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
145 Previous Clinical Trials
27,732 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,238 Patients Enrolled for Multiple Sclerosis
Washington University School of MedicineLead Sponsor
1,995 Previous Clinical Trials
2,296,674 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
52,260 Patients Enrolled for Multiple Sclerosis
Gregory WuPrincipal InvestigatorWashington University School of Medicine

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03963375 — Phase 4
Multiple Sclerosis Research Study Groups: Group 1: LP at Baseline and Week 5, Group 3: LP at Baseline and End of Year 1, Group 2: LP at Baseline and Week 10, Group 4: LP at Baseline and End of Year 2
Multiple Sclerosis Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT03963375 — Phase 4
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03963375 — Phase 4
~4 spots leftby May 2025
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