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The Kosair Charities Pediatric Clinical Research Unit at the University of Louisville invites adolescents and adults with Fragile X Syndrome to take part in a research study for a medication that is being developed to treat the symptoms of Fragile X Syndrome. We hope to learn more about its safety, how well your body manages it (tolerability), and how much medicine is in your body (pharmacokinetics).
This study is being sponsored (organized and paid for) by the pharmaceutical company Hoffmann-La Roche, and more information about this clinical trial can be found on the clinicaltrials.gov website at www.clinicaltrials.gov/ct2/show/NCT01517698?term=fragile+X&rank=26. It has been reviewed and approved by the University of Louisville Institutional Review Board (IRB # 12.0336), and is being conducted at U of L under the direction of Dr. Lisa Craft.
Both males and females between 16 and 50 years old can take part. This study is placebo controlled, which means that some patients will get the study medication, and some patients will get a placebo, which is like a “sugar pill” (does not contain active ingredient). After a screening period to determine eligibility, the study will last about 4 months. Throughout the study, there will be some psychological assessments, as well as some lab work and other safety monitoring assessments. Patients will be compensated for time/travel.
If interested, please contact:
Carrie Schanie, RN
Kosair Charities Pediatric Clinical Research Unit
231 E. Chestnut Street,
N-97 (2 East)
Louisville, KY 40202
(502) 629-5820 or (502) 620-0000 [pager]
IRB # 12.0336