Dear Friend of National Fragile X Foundation:
We would like to inform you of clinical research studies to find out if a new investigational drug is safe and has beneficial effects in people who have Fragile X syndrome.
This investigational drug is not yet available on the market, because it has not been approved in the United States by the Food and Drug Administration (FDA), or any other health authorities.
An international pharmaceutical company is sponsoring two clinical studies to test this investigational drug for the treatment of Fragile X syndrome. One study is in adolescents aged 12-17, and the other study is in adults, aged 18-45. These studies are being conducted at centers throughout the country.
The studies in adults and adolescents will last for about 16-20 weeks, including a screening period. They will generally involve eight visits to the clinical sites.
If you are interested in learning more about either or both studies, please call 1-888-669-6682 (1-888-NOW-NOVA).
Sincerely,
Novartis Study Team
To learn more, visit the website:
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome
Quorum Review Files # 27011 and # 25395