Testing lacosamide for chronic pain relief in pancreatitis patients

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

This study is testing if adding lacosamide to opioid treatment can help people with chronic abdominal pain from pancreatitis feel better and manage their pain safely.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (other)
• Locations: 5 sites (Stanford, California and 4 other locations)
• Trial ID: NCT05603702 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of lacosamide, an FDA-approved antiepileptic drug, when used alongside opioid therapy in patients suffering from chronic abdominal pain due to chronic pancreatitis. The study employs a dose-escalation approach to determine the maximum tolerated dose of lacosamide while monitoring for adverse effects and efficacy in reducing opioid-induced hyperalgesia. Participants will receive lacosamide for a week, with follow-up assessments to evaluate pain relief and safety. The trial aims to provide preliminary data on the use of lacosamide in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic pancreatitis who have been on opioid therapy for at least four weeks and continue to experience significant abdominal pain.

Not a fit: Patients who are not currently using opioids or those with contraindications to lacosamide will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option that enhances pain management for patients with chronic pancreatitis while minimizing the side effects associated with opioid use.

How similar studies have performed: While there is limited data on lacosamide specifically for chronic pancreatitis, the approach of targeting sodium channels to improve opioid efficacy has shown promise in other pain management studies.

Eligibility criteria

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.

Where this trial is running

Stanford, California and 4 other locations

• Stanford University — Stanford, California, United States (ACTIVE_NOT_RECRUITING)
• Indiana University — Indianapolis, Indiana, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (ACTIVE_NOT_RECRUITING)
• Ohio State University — Columbus, Ohio, United States (ACTIVE_NOT_RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Evan L Fogel, MD, MSc

Conditions: Chronic Pain, Chronic Pain Syndrome, Chronic Pancreatitis, Hyperalgesia, Opioid Use Disorder, Opioid-Related Disorders, Opioid Dependence, Chronic Abdominal Pain