Low frequency administration of 40mg GA in RRMS subjects (GALA study)

• Research type

  Research Study

• Full title

  A Multinational, multicentre, randomised, parallel group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40mg administered three times a week compared to placebo in a double blind design

• IRAS ID

  47104

• Contact name

  David Rog

• Sponsor organisation

  Teva Pharmaceuticals Limited

• Eudract number

  2009-018084-27

• Research summary

  Multiple Sclerosis (MS) is a chronic, inflammatory condition which leads to damage of the central nervous system, causing disability at various degrees and rates in different patients. Copaxone© (glatiramer acetate) (GA) is a disease-modifying drug that has been licensed for use in Relapsing-Remitting multiple sclerosis (RRMS) patients. The current dosing regimen requires daily injections of 20mg GA. This research will investigate a new dosing regimen of three injections per week of 40mg GA. The study will involve approximately 1350 subjects from participating countries including Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Romania, Russia, South Africa, Turkey, Ukraine, UK and the USA. Approximately sixteen (16) patients will be invited to participate from four (4) UK centres. The study will consist of a 30 day screening period followed by a 12 month double-blind, placebo-controlled treatment phase during which patients will be expected to attend approximately 3 monthly for five (5) visits. Subjects completing the 12 month double-blind treatment phase will be offered the opportunity to participate in an open-label extension phase where they will be treated with 40mg GA until the new dose strength becomes commercially available. It is expected that a new dosing regimen for GA will improve convenience of treatment by allowing fewer injections, provide reduced burden and increase treatment compliance in RRMS patients. It is also expected that there will be fewer side-effects that are normally associated with daily subcutaneous (under the skin) injections. Overall, the aim of this research is to provide a safer, more convenient treatment for RRMS patients.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  10/H1003/37

• Date of REC Opinion

  29 Jul 2010

• REC opinion

  Further Information Favourable Opinion