Past Activities
Design, Conduct and Interpretation of Clinical Trials in Movement Disorders

Course Program

29 October 2013
An overview on Parkinson's disease and Huntington's disease pathogenesis, clinical phenomenology and management
8:45-9:00 Welcome and organizational matters
9:00-10:30 Session 1: Parkinson’s disease
What causes Parkinson's disease?
Werner Poewe (Innsbruck, Austria)

Diagnosis of PD and the premotor stages
Werner Poewe (Innsbruck, Austria)
10:30-11:00 Break
11:00-12:30 Session 1 continued
Progression of PD and relevant clinical outcomes
Joaquim Ferreira (Lisbon, Portugal)

Recommendations for the management of PD
Olivier Rascol (Toulouse, France)
12:30-14:00 Lunch
14:00-15:30 Session 2: Huntington’s disease
Cause and genetics of HD
Bernhard Landwehrmeyer (Ulm, Germany)

Diagnosis of HD and the premotor stages
Ralf Reilmann (Munster, Germany)
15:30-16:00 Break
16:00-17:30 Session 2 continued
Clinical progression in HD and relevant clinical outcomes
Ralf Reilmann (Munster, Germany)

Potential HD biomarkers
Bernhard Landwehrmeyer (Ulm, Germany)
17:30-18:30 Session 3: Videos of illustrative cases of PD and HD
30 October 2013
An overview on Clinical Trial Methodology with specific reference to Parkinson's disease and Huntington's disease
9:00-9:45 The different types of clinical research in PD and HD
Cristina Sampaio (Princeton, New Jersey, USA)
9:45-10:30 Overview of clinical trial design options in PD and HD
Cristina Sampaio (Princeton, New Jersey, USA)
10:30-11:00 Break
11:00-11:45 Overview on outcome measurements in HD and PD
Ralf Reilmann (Munster, Germany) / Angelo Antonini (Venice, Italy)
11:45-12:30 The placebo effect in movement disorders
Olivier Rascol (Toulouse, France)
12:30-14:00 Lunch
14:00-14:45 Basic statistics for the design of clinical trials in HD and PD
C. Frost (London, UK)
14:45-15:30 The main bottlenecks of RCTs
Angelo Antonini (Venice, Italy)
15:30-16:00 Break
16:00-16:45 Critical appraisal of a clinical trial
Joaquim Ferreira (Lisbon, Portugal)
16:45-17:30 Systematic review of RCT and meta-analysis
Joaquim Ferreira (Lisbon, Portugal)
17:30-18:00 Past, Present and Future of therapeutic clinical research in Movement Disorders
31 October 2013
Workshops on specific examples of clinical trials in PD and HD
Attendees will be split into 3 to 4 working groups of 10-12 participants. Each group will receive a package presenting an imaginary scenario with a documentation summarizing the previous development steps allowing building-up the design of a clinical trial in PD or HD. Each scenario will have been elaborated in advance by the panel, in order to provide illustrative examples of the main types of issues discussed on the previous day.
8:30-11:00 Elaboration of the synopsis of a protocol. Participants of each working group will be asked to elaborate the synopsis of a protocol according to the proposed scenario and to focus mainly on primary and secondary objectives, study design, study duration, inclusion/exclusion criteria, primary and secondary outcome measurements rather than on statistical issues. Each working group will prepare such a synopsis under the supervision of 1 or 2 members of the Panel. Each group will designate a representative who will be in charge to summarize its conclusions in order to present it to the other working groups for global discussion later on.
11:00-11:30 Break
11:30-12-30 Discussion of working group 1 protocol by the entire audience
12:30-13:30 Lunch
13:30-14:30 Discussion of working group 2 protocol by the entire audience
14:30-15:30 Discussion of working group 3 protocol by the entire audience
15:30-16:30 Discussion of working group 4 protocol by the entire audience
16:30-17:00 Concluding remarks
Olivier Rascol (Toulouse, France) and Joaquim Ferreira (Lisbon, Portugal)

Course Directors
Joaquim Ferreira (Lisbon, Portugal)
Olivier Rascol (Toulouse, France)