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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether lacosamide — a medication used for nerve pain — can help reduce abdominal pain in people with chronic pancreatitis who are already taking opioids but still experiencing significant pain. It aims to find a safer pain management option for this difficult-to-treat condition. You may be eligible if: - You are 18 or older - You have a suspected or confirmed diagnosis of chronic pancreatitis with ongoing abdominal pain - You have been taking opioids (not methadone or suboxone) for at least 4 weeks for pancreatitis-related pain - Your average pain score is 4 or higher despite opioid use - You are able to swallow tablets - You meet specific blood count and liver/kidney lab requirements You may NOT be eligible if: - Your chronic pancreatitis is classified as indeterminate (YELLOW 1) - You participated in another investigational study in the last 30 days - You required IV opioids in the past 30 days due to rapidly worsening pain - You are allergic to lacosamide, carbamazepine, or oxcarbazepine - You are pregnant or breastfeeding - You have epilepsy or are taking anti-epileptic drugs (other than gabapentin/pregabalin) - You had abdominal surgery or a pain procedure in the last 90 days - You were hospitalized for pancreatitis or pain in the past 30 days - You currently take Suboxone or Methadone - You have had autoimmune or traumatic pancreatitis, or a pancreatic tumor - You have had a solid organ transplant or have HIV/AIDS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(5)

Stanford University

Stanford, California, United States

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05603702


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