RecruitingPhase 1NCT05603702

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

Sponsor

Indiana University

Enrollment

24 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Chronic Pancreatitis Chronic Pain Syndrome Hyperalgesia

Summary

The investigators propose to conduct a dose-escalation trial of an FDA-approved antiepileptic drug, lacosamide, added to opioid therapy in patients with chronic abdominal pain from chronic pancreatitis (CP). This pilot trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of lacosamide used concomitantly with opioids in this patient population to reduce the condition known clinically as opioid-induced hyperalgesia (OIH).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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;
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.
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.

Exclusion Criteria14

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 parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment;
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 (other than gabapentin and pregabalin);
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 30 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.

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Interventions

DRUGLacosamide

Study Visit 1: Baseline study assessments will be made and questionnaires completed in person, on day 0. Drug treatment days will then occur on days 1-7. Study Visit 2: Following completion of the 7-day drug treatment period, participants will have a face-to-face clinic visit on day 8 (with a 3 day grace period), where similar assessments and questionnaires will again be completed. Participants will return all unused drug at this visit, for disposal and to monitor compliance. A follow-up phone visit will occur on day 21 (with a 3 day window) to assess for adverse events and medication changes