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Restless Legs Syndrome: Phase II

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Restless Legs Syndrome: Phase II

Recruitment Challenges:
  • The projected screen failure rate at the onset was 25% which meant we needed to screen 200 subjects with 40 US trial sites
  • Shortly after the start of screening the screen failure rate rose to 40% and by mid-screening it was at 60%
  • We quickly needed to adjust the program to ensure a continuous flow of eligible subjects for screening at the trial sites
  • We used our in-house call/triage center to ensure only pre-screened subjects were referred and worked closely with the study coordinators to implement a robust follow-up program which ensured referred subjects presented to the trial sites for their screening appointments
  • We also listed the trial on our novel web site Clinical Trial Spotlight and designed a targeted internet campaign to heighten the awareness directly to the RLS patients
  • We worked with local trial sites to place targeted advertisement to ensure ROI
End Result:

Trial was fully enrolled 4 months ahead of schedule

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