STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis (STTEPP)
Chronic Pain, Chronic Pain Syndrome, Chronic Pancreatitis
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Pancreatitis, Pancreatitis, chronic, Chronic pain, Pain, Pancreatic Diseases, Digestive System Diseases
Eligibility Criteria
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/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. 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 or Methadone. 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.
Sites / Locations
- Stanford UniversityRecruiting
- Indiana UniversityRecruiting
- Mayo ClinicRecruiting
- Ohio State UniversityRecruiting
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Dose Escalation Level
In the first 3-patient cohort, the dose of lacosamide given is 50mg/d BID. Enrollment to the next higher dose cohort will be initiated only if none of the 3 participants exhibits a DLT in the 21 ±3 days following completion of the 7 day drug therapy. Dose escalation will proceed according to the Bayesian optimal interval (BOIN) design at incremental increase of 100mg/day in two divided doses. The maximum daily dose of lacosamide will be 400mg/day.