Cladribine in adults with first signs of Multiple Sclerosis
Research type
Research Study
Full title
A Phase III, randomised, double-blind, placebo-controlled, multi-center clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to Multiple Sclerosis
IRAS ID
6765
Sponsor organisation
Merck Serono International Switzerland
Eudract number
2008-003706-33
Clinicaltrials.gov Identifier
Research summary
Multiple Sclerosis (MS) is a chronic (persistent and lasting), inflammatory disease of the Central Nervous System and the most common disabling neurological condition affecting young adults.The body's immune system mistakenly attacks the myelin sheath (protective covering surrounding nerve fibres) or the cells that produce and maintain the myelin sheath. This eventually leads to the loss of nerve cells (neurons) that send and receive electrical signals over long distances within the body's sufferers can have recurrent attacks of predominantly neurological symptoms such as muscle weakness, pain or paralysis, sudden, involuntary contraction of muscle(s) group (spasm), headache, seizures and visual impairment. Current therapies aim to prevent attacks and disability and to return function to normal following an attack. There is currently no cure for MS.Merck Serono International a branch of laboratoires Serono S.A. are sponsoring a study to investigate the efficacy and safety of oral Cladribine (a licensed drug) as compared to placebo (a similar looking drug with no active substance) on the time to a potential conversion to clinically definite multiple sclerosis (CDMS) following a Clinically Isolated Syndrome (CIS) - an individual's first neurological episodeCladribine will be given to males and female patients aged 18-55 years who have suffered a CIS which could potentially lead to a diagnosis of MS.Patients of the study will be randomised (chosen by chance) into three groups: <ul> <li style="color: Treatment with high dose of Cladribine</li> <li style="color: Treatment with low dose Cladribine</li> <li style="color: Treatment with Placebo</li></ul>The patients and the study team will not know which treatment has been assigned. The study expects to recruit 576 evaluable patients from around 200 centres worldwide for 6 cycles of treatment (each consisting of 4-5 consecutive days of treatment) over 2 years. Patients will also undergo multiple tests and neurological assessments to evaluate their individual disease progression.Participants can voluntary take part in sub-studies, which will evaluate how the genetic (DNA) material as well as blood cells relate to the MS and how their body reacts to a certain drug.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
09/H0505/22
Date of REC Opinion
9 Jun 2009
REC opinion
Further Information Favourable Opinion