Oral Cladribine in Early Multiple Sclerosis (MS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

Key facts

Study ID

NCT00725985

Run by

EMD Serono Research & Development Institute, Inc.

People needed

617

Starts

2008-12-31

Expected to finish

2012-04-30

Last updated by the study team

2021-03-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 and 55 years old, inclusive
• Weighed between 40 to 120 kilogram (kg), inclusive
• Participant has experienced a single, first clinical event suggestive of MS within 75 days prior to the Screening visit, (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic
• Participant has at least two clinically silent lesions on the T2-weighted MRI scan, at screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid or periventricular or infratentorial on screening MRI
• Participant has EDSS 0 - 5.0 at Screening
• Participant has no medical history or evidence of latent tuberculosis infection (LTBI) or active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or a comparable sensitive test according to local regulations/guidelines (if the Mantoux test is not available), and/or a chest X-ray
• Participant has normal hematological parameters at Screening, as defined by the central laboratory that performed all the assessments
• If female, she must:
• be neither pregnant nor breast-feeding, nor attempting to conceive and
• use a highly effective method of contraception throughout the entire duration of the study and for 90 days following completion of the last dose of study medication. A highly effective method of contraception is defined as those which result in a low failure rate (that is less than 1 percent per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner, or
• be post-menopausal or surgically sterilized (Note: for Danish sites only, participants should use a hormonal contraceptive or intrauterine device for the duration of the trial)
• Male participants must be willing to use contraception to avoid impregnating partners throughout the study, and for 90 days following the last dose of study medication
• Be willing and able to comply with study procedures for the duration of the study
• Participant has to provide written informed consent voluntarily, including, for United states of America (USA), participant authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care
• Participant has refused any treatment already available for clinically isolated syndrome (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial Treatment Period of this study

You may not qualify if…

• Participant has a diagnosis of MS (per McDonald criteria, 2005)
• Participant has any other disease that could better explain the participant's signs and symptoms
• Participant has complete transverse myelitis or bilateral optic neuritis
• Participant using or has used any other approved MS disease modifying drug (DMD)
• Participant has used any investigational drug or undergone an experimental procedure within 12 weeks prior to Study day 1
• Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days after the oral or systemic corticosteroids or ACTH treatment. In case this interfered with MRI timing the screening period could be extended accordingly.
• Participant has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit of normal
• Participant suffered from current autoimmune disease other than MS
• Participant suffered from psychiatric illness (including history of, or concurrent, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the participant or could affect compliance with the study protocol
• Participant suffered from major medical illness such as cardiac (for example angina, congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic, metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease that would preclude the administration of oral cladribine
• Participant has a history of seizures not adequately controlled by medications
• Participant has a known allergy to cladribine, interferon-beta, the excipient(s) of the study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)
• Participant has any renal condition that would preclude the administration of gadolinium (for example acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m\^2])
• Participant has a history of chronic or clinically significant hematological abnormalities
• Participant has a history of active or chronic infectious disease or any disease that compromises immune function (for example human immunodeficiency virus positive [HIV+], human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection [LTBI] or TB, insulin-dependent diabetes).
• Participant has previously been screened in this study (signed an informed consent) and then withdrawn
• Participant has received any immunomodulatory or immunosuppressive therapy) at any time prior to Study Day 1, including, but not limited to, the following products: any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4 [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy
• Participant has received experimental MS treatment
• Participant has a history of alcohol or drug abuse
• Participant has intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen
• Participant has inability to administer subcutaneous injections either by self or by caregiver
• Participant has prior or current malignancy (with the exception of in situ basal or squamous cell skin cancer surgically removed without recurrence for at least five years)
• Participant has a positive stool hemoccult test at Screening

Where it is running

• Multiple Sclerosis Center Drive, Neurology Suite 701 — Newport Beach, California, United States
• University of Colorado at Denver Health Sciences — Denver, Colorado, United States
• Fort Collins Neurology — Fort Collins, Colorado, United States
• MS Center of Brevard MIMA Centry Research Associates — Melbourne, Florida, United States
• University of South Florida — Tampa, Florida, United States
• MS Center of Atlanta — Atlanta, Georgia, United States
• Bruce Hughes West Building — Des Moines, Iowa, United States
• Michigan Neurology Associates — Clinton Township, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Dennis Dietrich — Great Falls, Montana, United States
• University of Medicine and Dentistry of New Jersey School of Neurology — Stratford, New Jersey, United States
• Upstate Clinical Research LLC 3 — Albany, New York, United States
• Neurological Specialists of Long Island — Great Neck, New York, United States
• Multiple Sclerosis Center of Northeastern NY — New York, New York, United States
• Comprehensive MS Care Clinic at South Shore Multiple Sclerosis — Patchogue, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Meritcare Neuroscience Center Neurology — Fargo, North Dakota, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• MS Center of Oklahoma — Oklahoma City, Oklahoma, United States
• Neurology and Sleep Medicine — Bethlehem, Pennsylvania, United States
• Swedish Medical Center Cherry Hill — Seattle, Washington, United States
• Neurology & Neurological Association of Tacoma — Tacoma, Washington, United States
• Instituto Medico Rodriguez Alfici — Godoy Cruz, Argentina
• Hope Research Institute Medical Plaza LLC Desert Hills — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.