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

Launched by INDIANA UNIVERSITY · Oct 31, 2022

Keywords

ClinConnect Summary

The STTEPP clinical trial is studying the safety and tolerability of a medication called lacosamide in patients who have chronic abdominal pain due to a condition known as chronic pancreatitis. This trial is particularly focused on patients who are already using opioids for pain relief but may be experiencing increased pain sensitivity, a condition called opioid-induced hyperalgesia. The goal is to see if adding lacosamide to their treatment can help reduce this sensitivity while still being safe to use alongside opioids.

To be eligible for the trial, participants need to be at least 18 years old and have a confirmed diagnosis of chronic pancreatitis with ongoing abdominal pain, even while using opioids (like morphine or oxycodone). They must also be able to swallow oral tablets and meet certain health criteria. Participants can expect to be closely monitored for safety and tolerability as they receive lacosamide treatment, helping researchers gather important information about this potential new approach to managing their pain.

Gender

ALL

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.