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
