Who is eligible for clinical trial NCT05603702?

Participants must meet protocol criteria for Chronic Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05603702 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-01

STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis (NCT05603702)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Indiana University

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (17 items).

Location: Stanford University — Stanford, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

Stanford University — Stanford, California
Indiana University — Indianapolis, Indiana
Mayo Clinic — Rochester, Minnesota
Ohio State University — Columbus, Ohio
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗