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

Inclusion Criteria:

1. written informed consent and HIPAA authorization for release of personal healthinformation;

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 studydefinition with ongoing symptoms of abdominal pain;

4. patients must be maintained on an opioid (except methadone or suboxone) for 4 weeksprior 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, absoluteneutrophil 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 intervalon baseline 12-lead EKG.

Exclusion Criteria:

1. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria;

2. treatment with any investigational agent within 30 days prior to registration, orconcurrent participation in a clinical trial which involves another investigationalagent;

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 oroxcarbazepine;

5. pregnant or breastfeeding;

6. patient who has a diagnosis of epilepsy and/or is currently taking anti-epilepticdrugs (other than gabapentin and pregabalin);

7. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stoneremoval; celiac plexus block) within 90 days of enrollment.

8. hospitalization for pancreatitis exacerbation or pain management within 30 days ofenrollment

9. patient who currently takes Suboxone or Methadone.

10. other factors which might explain the patient's ongoing symptoms, at the discretionof the enrolling physician.

11. history of autoimmune or traumatic pancreatitis, or sentinel attack of acutenecrotizing pancreatitis which results in suspected disconnected duct syndrome.

12. primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cysticneoplasm (>1cms in size or main duct involvement), neuroendocrine tumors, and otheruncommon 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 anyeligible inclusion criteria).

16. participants must not have medical or psychiatric illnesses or ongoing substanceabuse that in the investigator's opinion would compromise their ability to toleratestudy interventions or participate in follow-up.