Clinical Trials

Inclusion Criteria:

• Written informed consent and HIPAA authorization for release of personal health information.
• ≥ 18 years old at the time of informed consent.
• Suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain.
• 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, with a daily morphine equivalent dose of 20-120mg.
• Ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥ 4, at enrollment).
• ECOG Performance Status of 0-2; (Oken et al., 1982).
• Ability to swallow and tolerate oral tablets.
• Females of childbearing potential must have a negative pregnancy test.
• The following laboratory parameters must be met: WBC count ≥ 3.0 K/mm^3, absolute neutrophil count ≥ 1.5 K/mm^3, hemoglobin ≥ 9 g/dL, platelets ≥ 75 K/mm^3, creatinine ≤ 1.5 mg/dl, bilirubin ≤ 1.5 x ULN, AST ≤ 3 ´ ULN, ALT  ≤ 3 ´ ULN; normal PR interval on baseline 12-lead EKG.

Exclusion Criteria:

• Subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria.
• Treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent.
• Rapidly escalating pain that requires hospitalization or intravenous opioid therapy.
• Known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine.
• Pregnant or breastfeeding.
• Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs.
• Abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment.
• Hospitalization for pancreatitis exacerbation or pain management within 90 days of enrollment.
• Patient who currently takes Suboxone, Methadone or uses Marijuana.
• Other factors which might explain the patient’s ongoing symptoms, at the discretion of the enrolling physician.
• History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome.
• Primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
• Pancreatic metastasis from other malignancies.
• History of solid organ transplant, HIV/AIDS.
• Known isolated pancreatic exocrine insufficiency (e.g,. in the absence of any eligible inclusion criteria).
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.