Lacosamide in Patients With Painful Chronic Pancreatitis

Overview

About this study

The purpose of this study is to determine the safety, tolerability and dose-limiting toxicity of adding lacosamide to opioid therapy for the treatment of abdominal pain due to chronic pancreatitis (CP). Also, to assess the feasibility of performance of a pilot study adding lacosamide to opioid therapy in these subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Santhi Swaroop Vege, M.D.

Open for enrollment

Contact information:

Heidi Gage CCRP

(507) 266-6482

Gage.Heidi@mayo.edu

More information

Publications

Publications are currently not available