Proof of Mechanism Study of GSK239512 in RRMS

• Research type

  Research Study

• Full title

  Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

• IRAS ID

  114151

• Contact name

  Jeremy Chataway

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2012-003627-38

• ISRCTN Number

  xx

• Research summary

  Relapsing Remitting Multiple Sclerosis (RRMS) is a chronic progressive neurologic disorder affecting the central nervous system (brain and spinal cord). Nerves control many functions such as movement and sensation by transmitting electrical impulses. Nerves are surrounded by an insulating sheath or coating called myelin, which ensures efficient transmission of the impulses. In multiple sclerosis there is damage (demyelination) to this coating meaning that the nerve may not work as efficiently. This damage may lead to the development of symptoms (relapse). The symptoms experienced depend on the nerves involved and the severity of the damage. There is a naturally occurring process called remyelination which tries to repair damage to the nerve coating. This process can allow the nerve to carry on functioning and is thought to maintain low levels of disability in the early stages of Multiple Sclerosis (MS). However, remyelination is rarely complete and for long term MS patients remyelination failure becomes more common, leading to patients experiencing more symptoms. Therefore, promotion of remyelination may ultimately provide functional recovery and potentially prevent irreversible disability. This is not possible with current MS therapies which try to limit the severity of the initial nerve damage. This study is designed to assess whether the study drug (GSK239512) can enhance the process of repair (remyelination) described above, in patients with RRMS. This will be measured by assessing brain images taken with MRI scans (Magnetic Resonance Imaging). These scans will be done at approximately 6 week intervals. Half of the patients in the study will receive the study drug while half will receive a placebo (dummy drug).These will be given as tablets taken once daily for a total of 48 weeks. The study drug is not anticipated to reduce the number of relapses; therefore patients will also continue to use their current therapy (Disease Modifying Drugs).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/1757

• Date of REC Opinion

  15 Jan 2013

• REC opinion

  Further Information Favourable Opinion