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. 2014 Oct 28;2014(10):CD008953. doi: 10.1002/14651858.CD008953.pub2

EUCTR 2012‐005312‐26‐DE.

Trial name or title Sustained release 4‐aminopyridine (Fampyra®) in cerebellar gait disorder
Methods Randomised, double‐blind, placebo‐controlled, cross‐over trial
Participants Men or women aged 18 to 80 with a clinically evaluated diagnosis of cerebellar ataxia with at least 2 points on the SARA
Interventions Sustained released 4‐aminopyridine (Fampyra) or placebo
Outcomes Primary outcomes:
  1. Logarithmised gait variability at maximum walking speed (CVmax (%))

  2. Logarithmised individual preferred walking speed (G_pref)


Secondary outcomes:
  1. Gait variability at maximum walking speed at the end of the 12‐week treatment phase

  2. Difference in the (relative) change of the individual preferred walking speed at the end of the 12‐week treatment phase versus baseline

  3. Quantitative description or comparison of the changes in various ataxia, mobility and quality of life scores within the 2 treatment groups versus baseline (after 14 days, 12 weeks or follow‐up visit)

  4. Number of falls

  5. Frequency of (severe) adverse effects

Starting date 18 March 2013
Contact information IFB LMU, Marchioninistr. 15, 81377, Munich, Germany. FACEG.studie@med.uni‐muenchen.de
Hospital of the University of Munich
Notes