GTR and Copaxone equivalence study (GATE)

• Research type

  Research Study

• Full title

  Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects

• IRAS ID

  83242

• Contact name

  Basil Sharrack

• Sponsor organisation

  Synthon BV

• Eudract number

  2011-000888-27

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  GTR is a new medicinal product that being developed by Synthon BV. GTR is similar to Copaxone, an effective drug used for treatment of Multiple Sclerosis. The main objective of this phase III trial is to demonstrate that GTR is as safe and efficacious as Copaxone.This trial consists of two parts: In double-blind Part 1 safety and tolerability of GTR will be compared to Copaxone and placebo. Patients with Multiple Sclerosis will be randomly assigned to receive daily 20 mg GTR, 20 mg Copaxone or placebo for a period of 9 months. During Part 1 of the study, patients will return to the clinic for assessment visits during months 1, 3, 6, 7, 8 and 9. MRI scans will be repeated at the beginning of the study and at months 7, 8, and 9. Disability status will be assessed by standard method (Enhanced disability status scale, EDSS) at months 6 and 9. Vital signs, adverse events, blood clinical chemistry and haematology testing will be assessed during all subsequent visits. Upon completion of all scheduled assessments for the 9 months visit, patients will have an opportunity to participate in Part 2 of the trial. In Part 2 all patients will be treated with 20 mg daily GTR for another 15 months. Safety and efficacy parameters will be assessed during visits to the clinic at months 12, 18 and 24. 750 patients will participate in the study worldwide. The majority of sites will be located in Europe and North America, but sites in other locations may also be included.

• REC name

  North East - York Research Ethics Committee

• REC reference

  11/NE/0226

• Date of REC Opinion

  24 Oct 2011

• REC opinion

  Further Information Favourable Opinion