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NCT05603702

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Indiana University
~21 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Lacosamide

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity of lacosamide in combination with opioids in CP patients will be measured by the number of grade 3 or4 toxicities reported via the CTCAE v5.0, between Day 1 through 21 day follow up.
Measured over Day 1, 21 day follow up
+3 more outcomes measured

Conditions

Chronic Pain
Chronic Pain Syndrome
Chronic Pancreatitis
Hyperalgesia
Opioid Use Disorder
Opioid-Related Disorders
Opioid Dependence
Chronic Abdominal Pain
ERCP
Pancreatic Surgery

Explore related trials

Chronic Pancreatitis

Where it's being run

5 sites across 5 states
California1
Indiana1
Minnesota1
Ohio1
Pennsylvania1

Study leadership

  • Aynur Unalp-Arida, MD, PhD · STUDY_DIRECTOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Dose-limiting toxicity of lacosamide in combination with opioids in CP patients will be measured by the number of grade 3 or4 toxicities reported via the CTCAE v5.0, between Day 1 through 21 day follow up.Day 1, 21 day follow up

    Dose-limiting toxicity of combination lacosamide and opioids. Patients will be examined and graded for subjective/objective evidence of developing grade 3 or 4 toxicities according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  • Tolerability of lacosamide in combination with opioids in CP patients will be evaluated by the percentage of compliance in taking lacosamide pills as directed between Day 1 and Day 7.Day 1, Day 7

    Tolerability will be assessed by compliance with the intervention. Subjects will be evaluated for completing the 7-day trial. The percent of subjects taking 100%, 75%, 50% and \<50% of tablets will be recorded.

  • Feasibility of performance of a pilot study adding lacosamide to opioid therapy in CP patients based on recruitment rate: measured by the proportion of eligible patients who continue from the screening visit to the enrollment visit.Screening visit, Enrollment visit

    Recruitment rate (proportion of eligible patients approached who agree to participate)

  • Feasibility of performance of a pilot study adding lacosamide to opioid therapy in CP patients based on retention rate measured by the change from the screening visit to the 21 day follow-up visit.Screening visit, 21 day follow-up

    Dropout rate, including qualitative assessment of barriers to retention.