Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders

  • Email
  • Help

Details

TitleRegulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders
Date10/10/2014 - 10/10/2014
LocationEuropean Medicines Agency, London, UK
SummaryThis workshop brings together patient representatives, healthcare professionals, regulators, pharma and ethicists to discuss trial designs in neuromyelitis optica (NMO), a rare neurological disorder. For evidence of efficacy, in NMO, the choice of comparator is problematic. The severity/lack of reversibility of NMO relapses, indicate that placebo comparators are difficult but evidence for current treatments appears lacking. Different regulatory agencies have different views on comparators in NMO attack prevention. For a rare debilitating disease with unmet medical need, a wider debate is being held to facilitate drug development for the benefit of NMO patients. See 'Documents’ tab for agenda and 'Multimedia' tab for video of the workshop.

All documents

Name Language First published Last updated
Report of the regulatory workshop on clinical trials designs in neuromyelitis optica spectrum disorders (English only) 2015-06-16  
Agenda - Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders (English only) 2014-07-07 2014-10-07
Registration form - Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders (English only) 2014-07-07  
Speaker biographies - Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders (English only) 2014-10-23  
Presentation - Setting the scene: Neuromyelitis optica (Jackie Palace) (English only) 2014-10-23  
Presentation - Natural history of neuromyelitis optica (Friedemann Paul) (English only) 2014-10-23  
Presentation - Diagnostic criteria for neuromyelitis optica 2014 (Brian G. Weinshenker) (English only) 2014-10-23  
Presentation - Clinical view on current standard of care in neuromyelitis optica (R. Marignier) (English only) 2014-10-23  
Presentation - Neuromyelitis optica: Is there a standard of care? (Eliezer Katz) (English only) 2014-10-23  
Presentation - Non-Placebo and Add on Clinical Trials (Warren W Wasiewski) (English only) 2014-10-23  
Presentation - Neuromyelitis optica: Is there treatment equipoise? (Bruce Cree) (English only) 2014-10-23  
Presentation - Methods to manage risk in a placebo trial (Susan VanMeter, Sarah Kavanagh) (English only) 2014-10-23  
Presentation - Neuromyelitis optica testimonial - Speech (Irene Wilson) (English only) 2014-10-23  
Presentation - Neuromyelitis optica testimonial (Irene Wilson) (English only) 2014-10-23  
Presentation - The ethics of placebo controlled studies - Speech (Simon Woods) (English only) 2014-10-23  
Presentation - Clinical trials designs in neuromyelitis optica and spectrum disorders: United States Perspective (Wiley A. Chambers) (English only) 2014-10-23  
Presentation - The ethical considerations of placebo study design in neuromyelitis optica (M. Rosa) (English only) 2014-10-23  
Presentation - Clinical trials designs in neuromyelitis optica and spectrum disorders: Europen Union clinical view (M. Isabel Leite) (English only) 2014-10-23  
Presentation - Endpoints in a treatment trial in neuromyelitis optica: Clinician’s view (Anu Jacob) (English only) 2014-10-23  
Presentation - Clinical trials designs in neuromyelitis optica and spectrum disorders: Endpoints industry (Ayesh Perera) (English only) 2014-10-23  
Presentation - Development of drugs for paediatric neuromyelitis optica (Cheryl Hemingway) (English only) 2014-10-23  
Presentation - Development of drugs in paediatric neuromyelitis optica and neuromyelitis optica spectrum disorders: Industry perspective (Josephine Glover) (English only) 2014-10-23  

Media Videos


Video recording

A video recording is available. 

To view use the ‘Multimedia’ tab.

Related information