Safety and Pharmacology Study of VP 20629 (now called SHP622) in Adults With FA
Ages: 18-45
Locations: Children's Hospital of Philadephia (CHOP), Emory, University of South Florida, University of Iowa, UCLA
Details: This is a Phase 1 study sponsored by Shire (formerly initiated by ViroPharma) designed to evaluate dosage and safety of VP20629, a naturally occurring small molecular weight drug compound that can prevent oxidative stress to improve mitochondrial function. Participation in this study requires both outpatient and inpatient visits. Subjects in the second arm need to stay in the hospital for 10 days. In the second arm, subjects will receive multiple doses of VP 20629 (300 mg, 600 mg, or 900 mg total daily dose) or placebo. VP20629 or placebo will be administered every 8 hours for 7 days with a single morning dose on Day 8.
Children's Hospital of Philadelphia (CHOP), Philadelphia, PA
Principal Investigator: Dr. David Lynch
Coordinators:
Lauren Seyer from CHOP/ Tel.: (267) 426-9738; Email: seyerl@email.chop.edu
Debbie Foerster from CHOP/ Tel.: (267) 426-7584; Email: foerster@email.chop.edu
CHOP study ad: http://curefa.org/_pdf/VP20629ClinicalTrial.pdf
Emory University, Atlanta, GA
Principal Investigator: Dr. George Wilmot
Coordinator: Rebecca McMurray, *NOTE New Phone Number* Tel: 404-712-7013; Email: rmcmurr@emory.edu
Emory study ad: www.curefa.org/_pdf/EmoryTrialVP20629.pdf
University of South Florida, Tampa, FL
Principal Investigator: Dr. Theresa Zesiewicz
Coordinator: Kevin Allison, Tel: (813) 974-5909; email: kgalliso@mail.usf.edu
University of Iowa, Iowa City, IA
Principal Investigator: Dr. Kathy Mathews
Coordinator: Carrie Stephan, Tel: (319) 356-2673; email: carrie-stephan@uiowa.edu
UCLA Medical Center, Los Angeles, CA
Principal Investigator: Dr. Susan Perlman
Coordinator: Brian Clemente, Tel: (310) 794-1225; email: bclemente@mednet.ucla.edu
UCLA study ad: http://curefa.org/_pdf/UCLA-Trial-VP20629.pdf
