C08-001

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants.

• IRAS ID

  29966

• Contact name

  Dimitri Kullmann

• Sponsor organisation

  Alexion Pharmaceuticals Inc.

• Eudract number

  2009-014669-13

• Clinicaltrials.gov Identifier

  NCT00727194

• Research summary

  To date, Alexion has collaborated with leading clinical and scientific MG experts in the development of eculizumab in Myasthenia Gravis (MG). Alexion will evaluate the safety of eculizumab in this randomized, double-blind, placebo-controlled cross-over trial in patients with generalized MG. In this trial, patients will receive eculizumab (or placebo) in addition to standard maintenance treatments such as corticosteroids. This initial trial will allow Alexion to characterize the potential safety and efficacy of eculizumab in the management of a population of patients with MG. If positive safety and efficacy data are obtained in this study, additional trials may be designed to further characterize the efficacy of eculizumab for this indication.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0714/61

• Date of REC Opinion

  29 Dec 2009

• REC opinion

  Further Information Favourable Opinion