Clinical Research Consortium

The execution of clinical studies requires extensive planning, cooperation, and collaboration to protect the safety of participants and the integrity of valuable data. To initiate and implement clinical studies more quickly and effectively, researchers from five TSC Clinics together with the TSC Alliance formed the TSC Clinical Research Consortium in 2012.

Current Clinical Studies

• CURRENTLY ENROLLING: Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study (TSC-STEPS)
• CURRENTLY ENROLLING: Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
• Preventing Epilepsy using Vigabatrin in Infants with TSC (PREVeNT) — Results Available Spring 2023

Completed Clinical Trials

• Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC
• Early Biomarkers of Autism in Infants with TSC

Related Websites

• TSC Autism Center of Excellence Research Network (TACERN)
• Developmental Synaptopathies Consortium

Participating Sites and Principal Investigators

• Beaumont Children’s Hospital (Danielle Nolan, MD)
• Boston Children’s Hospital (Mustafa Sahin, MD, PhD)
• Children’s Hospital Philadelphia (Katherine Taub, MD)
• Children’s National Health System (William McClintock, MD)
• Cincinnati Children’s Hospital Medical Center (Darcy Krueger, MD, PhD)
• Duke University (Klaus Werner, MD, PhD)
• Minnesota Epilepsy Group (Michael Frost, MD)
• Seattle Children’s Hospital (Stephanie Randle, MD)
• Stanford University (Brenda Porter, MD, PhD)
• University of Alabama at Birmingham (Martina Bebin, MD, MPA)
• University of California, Los Angeles (Shafali Jeste, MD and Rajsekar Rajaraman, MD)
• University of North Carolina Chapel Hill (Jamie Capal, MD)
• University of Texas Health Science Center at Houston (Hope Northrup, MD and Mary Kay Koenig, MD)
• Washington University St. Louis (Michael Wong, MD, PhD)

Partnering

Investigators and sponsors from other institutions are invited to contact Dr. Steve Roberds at the TSC Alliance via sroberds@tscalliance.org or any principal investigator at participating sites to find out how to partner with the TSC Clinical Research Consortium.

Acknowledgements

Thanks to generous donations from the Cowlin Family Fund, the TSC Alliance supported early establishment of the data coordinating center and dedicated clinical coordinator time in 2012 and 2013 to help accelerate launch of the first studies. Clinical studies have been funded primarily by the National Institutes of Health with supplemental funding from the TSC Alliance.