Safety, Tolerability, and Dose-Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis: Protocol for a Phase 1 Clinical Trial to Determine Safety and Identify Side Effects

Evan L Fogel   ¹ , MSc, MD ;   Jeffrey J Easler   ¹ , MD ;   Ying Yuan   ² , PhD ;   Dhiraj Yadav   ³ , MPH, MD ;   Darwin L Conwell   ³ , MSc, MD ;   Santhi Swaroop Vege   ⁴ , MD ;   Samuel Y Han   ⁵ , MS, MD ;   Walter Park   ⁶ , MD ;   Vanessa Patrick   ¹ , RN ;   Fletcher A White   ⁷ , MSc, PhD

¹ Department of Medicine, School of Medicine, Indiana University, Indianapolis, IN, United States

² Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States

³ Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States

⁴ Department of Internal Medicine, Mayo Clinic, Rochester, MN, United States

⁵ Department of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH, United States

⁶ Department of Medicine, Stanford University Medical Center, Stanford, CA, United States

⁷ Department of Anesthesia, School of Medicine, Indiana University, Indianapolis, IN, United States