Clinical Trials

A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Type of Study/Intervention

Drug

Recruitment Status

Closed

Form of MS

Neuromyelitis optica

Brief summary

To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.

Inclusion criteria

  • Men and women 18 years or older with diagnosis of NMO/NMOSD
  • Confirmation of NMO/NMOSD status: a) AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years; or b) AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.
  • EDSS <= 7.5 (8 in special circumstances)
  • Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Exclusion criteria also apply – for full details visit ClinicalTrials.gov

Anticipated start date

November 2014

Recruitment contacts

Dr. Neil Shuey
Contact Tina Chen
St Vincent’s Hospital (Melbourne)
Email: [email protected]
Phone: 03 9231 3557

Further details

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

Region

VIC

Last updated

29/07/2019

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