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Lacosamide for Chronic Pancreatitis (STTEPP Trial)

Phase 1

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years old at the time of informed consent

Ability to swallow and tolerate oral tablets

Must not have

Primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors

Rapidly escalating pain that requires hospitalization or intravenous opioid therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening visit, enrollment visit

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an epilepsy drug to see if it can reduce pain when used along with opioids to treat chronic abdominal pain in CP patients. Safety & tolerability will assess if it works.

Who is the study for?

This trial is for adults with chronic pancreatitis who still experience abdominal pain despite opioid use. They must be able to take oral tablets, not have had certain pancreatic procedures recently, and not be on methadone or suboxone. Women of childbearing age need a negative pregnancy test.

What is being tested?

The STTEPP trial is testing the safety and tolerability of Lacosamide, an antiepileptic drug, when added to opioid therapy in patients with chronic pancreatitis to see if it can reduce pain that opioids alone haven't managed.

What are the potential side effects?

Lacosamide may cause side effects such as dizziness, headache, nausea, and fatigue. It might also affect balance or coordination and could potentially interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can swallow and tolerate oral tablets.

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I am able to care for myself and perform daily activities.

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I am of childbearing age and have a negative pregnancy test.

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I have chronic pancreatitis with ongoing abdominal pain.

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I still experience significant abdominal pain despite taking painkillers.

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I still experience significant abdominal pain despite taking painkillers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pancreatic tumor is one of several types, including adenocarcinoma or a suspected large cyst.

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I need hospital care or strong painkillers given through a vein for my severe pain.

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I have a condition where my pancreas does not produce enough digestive enzymes.

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I have epilepsy or am taking medication for it.

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I am currently taking Suboxone or Methadone.

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I have had pancreatitis due to an autoimmune condition, injury, or a severe attack causing duct issues.

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My cancer has spread to my pancreas from another part of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 21 day follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 21 day follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 21 day follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioids

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 procedure

+1 more

Secondary study objectives

Efficacy of adding lacosamide to opioid therapy for the treatment of abdominal pain due to CP by a 25% decrease in morphine milligram equivalents (MME) of opioid use from the Screening visit to Follow-up visit day 8.

Efficacy of adding lacosamide to opioid therapy for the treatment of abdominal pain due to CP by a 50% decrease in BPI-SF average pain score from the Screening visit to the Day 8 visit.

Efficacy of adding lacosamide to opioid therapy for the treatment of abdominal pain due to CP by a 50% decrease in the VAS score from the Screening visit to the Follow-up visit day 8..

+1 more

Side effects data

From 2011 Phase 4 trial • 100 Patients • NCT01235403

42%

Dizziness

Headache

Asthenia

Status epilepticus

Gait disturbance

Partial seizures with secondary generalisation

Diplopia

Nausea

Coma

100%

80%

60%

40%

20%

Study treatment Arm

Lacosamide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation LevelExperimental Treatment1 Intervention

In the first 3-patient cohort, the dose of lacosamide given is 50mg/d BID. Enrollment to the next higher dose cohort will be initiated only if none of the 3 participants exhibits a DLT in the 21 ±3 days following completion of the 7 day drug therapy. Dose escalation will proceed according to the Bayesian optimal interval (BOIN) design at incremental increase of 100mg/day in two divided doses. The maximum daily dose of lacosamide will be 400mg/day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lacosamide

2008

Completed Phase 4

~4360

0 / 14Eligibility criteria met