Principal Investigator

Medical Director of EMPOWER Study, Biogen Idec

Site-PI

Khema Sharma, MD
Michael Benatar, MD, PhD (Site sub-PI)

Summary

This is a randomized, double-blind, placebo-controlled study for patients with a clinical diagnosis of familial or sporadic Amyotrophic Lateral Sclerosis (ALS). The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.

Eligibility criteria

• Aged 18 to 80 years old, inclusive, on Day 1.
  
• Diagnosis of sporadic or familial ALS.
  
• Onset of first ALS symptoms within 24 months prior to Day 1.
  
• World Federation of Neurology El Escorial criteria are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis.
  
• Upright slow vital capacity (SVC) of 65% or more at screening.
  
• Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.
  
• Must be able to swallow tablets at the time of study entry.

Funding agency

Biogen Idec Inc.

Collaborators

http://www.clinicaltrials.gov/ct2/show/study/NCT01281189?term=NCT01281189&rank=1&show_locs=Y#locn

Research Coordinator

Julie Steele, RN
Alex Waltz, MA

Contact information

Email: JSteele@med.miami.edu

Links

http://www.clinicaltrials.gov/ct2/show/NCT01281189?term=NCT01281189&rank=1

Presentations / Publications