Dear Rett Community,
Today we took a significant step forward with the trofinetide clinical development program initiating the pivotal Phase 3 LAVENDER study. As we have shared before, LAVENDER is a 12-week study that will evaluate the efficacy and safety of trofinetide versus placebo in approximately 180 girls and young women aged 5 to 20 years with Rett syndrome.
At this time, 16 clinical study sites are expected to participate in the Phase 3 LAVENDER study with additional sites possibly added as the trial progresses. Study sites in Phoenix, Arizona, Houston, Texas, and Chicago, Illinois have started screening for the study. Remaining study sites in the following cities will begin screening later this year and into early 2020:
- Aurora, CO
- Baltimore, MD
- Birmingham, AL
- Boston, MA
- Cincinnati, OH
- Cleveland, OH
- Greenwood, SC
- La Jolla, CA
- Nashville, TN
- New York City, NY
- Philadelphia, PA
- St. Louis, MO
- St. Paul, MN
If you have visited the trial web site, www.rettsyndromestudies.com to register your participation interest, please know all of your information has been appropriately recorded and passed on to the closest clinical trial site available. The sites are all working as quickly as they can to meet the key requirements to conduct this study. As soon as each trial site is able to begin the study, a site coordinator or a member of the ACADIA Medical Affairs team will be in touch to discuss potential screening or provide additional information.
For families who wish to learn more about the LAVENDER study, please visit www.rettsyndromestudies.com. If you wish to reach a member of our Medical Affairs team with questions about trofinetide, please contact us at [email protected].
Thank you for your continued support. Your unwavering dedication to your girls reminds us each day why we are pursuing development of an FDA-approved treatment for Rett syndrome.
All our best,
The ACADIA Rett Team