Clinical Trials

A Double Blind Trial To Evaluate The Safety And Efficacy Of Eculizumab In Relapsing Neuromyelitis Optica (NMO) Patients (PREVENT Study)

Type of Study/Intervention

Drug

Recruitment Status

Recruiting

Form of MS

Neuromyelitis optica

Brief summary

The primary objective of the study is to assess the efficacy and safety of eculizumab treatment as compared to placebo in relapsing NMO patients using a time to first relapse study design.

Eculizumab is an experimental treatment given by intravenous (IV) infusion once a week for four weeks followed by an infusion once a fortnight for the two years of the trial. Patients will be randomised to receive either eculizumab or placebo and both patients and treating doctors will be blinded as to which treatment arm they are in.

The efficacy of the treatment will be assessed by time to first relapse following study entry. Overall safety and tolerability of eculizumab  will also be monitored by adverse events, vital signs and laboratory assessments

Inclusion criteria

  • Male or female patients ≥ 18 years old
  • Diagnosis of NMO or NMO spectrum disorder
  • All patients must be NMO-IgG seropositive
  • Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months (with at least 1 relapse in the 12 months prior to the Screening)
  • EDSS score ≤7
  • Immunosuppressive therapy is allowed provided patients have been on a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study

Exclusion Criteria

  • Use of rituximab within 3 months prior to screening
  • Use of mitoxantrone within 3 months prior to screening
  • Use of IVIg within 3 weeks prior to screening

Recruitment contacts

Brain and Mind Research Institute, Camperdown, NSW
Liverpool Hospital, Liverpool, NSW
Griffith University, Gold Coast, Queensland
St. Vincent’s Hospital, Fitzroy, Victoria

Alexion Pharmaceuticals
Email: [email protected]

Further details

Full details of the trial can be found on clinicaltrials.gov.

Region

NSW/VIC/QLD

Last updated

April 2016

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