Could a seizure drug ease pancreatitis pain and reduce opioid side effects?
NCT ID NCT05603702
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding lacosamide, a drug normally used for seizures, can safely help people with chronic pancreatitis who still have abdominal pain despite taking opioids. The study involves 21 adults who will take lacosamide for 7 days alongside their usual opioid medication. The main goals are to check for serious side effects and see if the drug is tolerable, with a secondary look at whether it reduces pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lacosamide (also known as VIMPAT)
- What this could lead to
- If this trial succeeds, it could point toward a new way to manage chronic abdominal pain in pancreatitis patients while reducing the pain caused by long-term opioid use.
- What could go wrong
- This is a very early, small phase 1 trial with only 21 participants. It is designed mainly to test safety and tolerability, not effectiveness. The results may not apply to all patients, and the drug may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. written informed consent and HIPAA authorization for release of personal health information; 2. ≥ 18 years old at the time of informed consent; 3. suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain; 4. 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; 5. ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment); 6. ECOG Performance Status of 0-2;(Oken et al., 1982) 7. ability to swallow and tolerate oral tablets; 8. females of childbearing potential must have a negative pregnancy test; 9. 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: 1. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria; 2. treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent; 3. rapidly escalating pain that requires parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment; 4. known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine; 5. pregnant or breastfeeding; 6. patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs (other than gabapentin and pregabalin); 7. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment. 8. hospitalization for pancreatitis exacerbation or pain management within 30 days of enrollment 9. patient who currently takes Suboxone or Methadone. 10. other factors which might explain the patient's ongoing symptoms, at the discretion of the enrolling physician. 11. history of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome. 12. primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 13. pancreatic metastasis from other malignancies. 14. history of solid organ transplant, HIV/AIDS. 15. known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria). 16. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana University
Indianapolis, Indiana, 46202, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Ohio State University
Columbus, Ohio, 43210, United States
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Stanford University
Stanford, California, 94305, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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