STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis

Eligibility Criteria

• 1. written informed consent and HIPAA authorization for release of personal health information;
• 2. ≥ 18 years old at the time of informed consent;
• 3. suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain;
• 4. patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis;
• 5. ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment);
• 6. ECOG Performance Status of 0-2;(Oken et al., 1982)
• 7. ability to swallow and tolerate oral tablets;
• 8. females of childbearing potential must have a negative pregnancy test;
• 9. the following laboratory parameters must be met: WBC count ≥ 3.0 K/mm3, absolute neutrophil count ≥ 1.5 K/mm3, hemoglobin ≥ 9 g/dL, platelets ≥ 75 K/mm3, creatinine ≤ 1.5 mg/dl, bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN; normal PR interval on baseline 12-lead EKG.
• 1. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria;
• 2. treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent;
• 3. rapidly escalating pain that requires parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment;
• 4. known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine;
• 5. pregnant or breastfeeding;
• 6. patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs (other than gabapentin and pregabalin);
• 7. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment.
• 8. hospitalization for pancreatitis exacerbation or pain management within 30 days of enrollment
• 9. patient who currently takes Suboxone or Methadone.
• 10. other factors which might explain the patient's ongoing symptoms, at the discretion of the enrolling physician.
• 11. history of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome.
• 12. primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
• 13. pancreatic metastasis from other malignancies.
• 14. history of solid organ transplant, HIV/AIDS.
• 15. known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria).
• 16. participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in follow-up.