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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit, enrollment visit
Awards & highlights
STTEPP Trial 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.Check my eligibility
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.See study design
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.
STTEPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can swallow and tolerate oral tablets.
Select...
I am able to care for myself and perform daily activities.
Select...
I am of childbearing age and have a negative pregnancy test.
Select...
I have chronic pancreatitis with ongoing abdominal pain.
Select...
I still experience significant abdominal pain despite taking painkillers.
Select...
I still experience significant abdominal pain despite taking painkillers.
STTEPP Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreSide effects data
From 2011 Phase 4 trial • 100 Patients • NCT0123540342%
Dizziness
8%
Headache
5%
Asthenia
1%
Partial seizures with secondary generalisation
1%
Gait disturbance
1%
Status epilepticus
1%
Diplopia
1%
Nausea
1%
Coma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lacosamide
STTEPP 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
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,217 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,958 Total Patients Enrolled
Aynur Unalp-Arida, MD, PhDStudy DirectorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic tumor is one of several types, including adenocarcinoma or a suspected large cyst.I need hospital care or strong painkillers given through a vein for my severe pain.I am 18 years old or older.I can swallow and tolerate oral tablets.You have an indeterminate CP (YELLOW 1) according to PROCEED criteria.I have a condition where my pancreas does not produce enough digestive enzymes.I have epilepsy or am taking medication for it.Other reasons for your symptoms, as decided by the doctor enrolling you in the trial.I have not had abdominal surgery or specific pain treatments in the last 90 days.I am able to care for myself and perform daily activities.I am currently taking Suboxone or Methadone.I am of childbearing age and have a negative pregnancy test.Your blood and organ function tests must show certain levels within the normal range. This includes white blood cells, red blood cells, platelets, kidney function, liver function, and heart rhythm.I was hospitalized for pancreatitis or its pain management in the last 90 days.I have chronic pancreatitis with ongoing abdominal pain.You are allergic to lacosamide, carbamazepine, or oxcarbazepine.You have had a solid organ transplant or have HIV/AIDS.I have had pancreatitis due to an autoimmune condition, injury, or a severe attack causing duct issues.My cancer has spread to my pancreas from another part of my body.I still experience significant abdominal pain despite taking painkillers.I have been on opioids (not methadone/suboxone) for pancreatitis pain for 4 weeks.I still experience significant abdominal pain despite taking painkillers.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Level
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aim does this research endeavor hope to accomplish?
"This trial aims to assess the compliance and tolerability of lacosamide when taken with opioid therapy over a 21 day period. Additional objectives include establishing efficacy through reducing morphine milligram equivalents by 25%, decreasingCompat-SF pain severity scores by 50% as evaluated using a validated self-reported tool, and diminishing Visual Analog Score (VAS) readings by half. Patients will be asked to track all opioids consumed in a drug diary from the screening visit until Day 8 of the study intervention."
Answered by AI
Has the Dose Escalation Level been sanctioned by the FDA?
"Our team at Power has judged that the safety of Dose Escalation Level is a 1, as it is only in Phase 1 and therefore there are scant data points to affirm both efficacy and security."
Answered by AI
Is enrollment currently ongoing for this research trial?
"This research trial, which was initially published on November 1st 2022 and last altered 9 days later, is not recruiting any additional candidates at present. However, clinicaltrials.gov currently lists 1611 other studies that are actively searching for participants to join their trials."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Stanford University
Why did patients apply to this trial?
I have chronic pain but really got hurt in April of 2023. I started taking pain pills because the doctor would not give me anything for the pain. I have an addictive personality and now I can't seem to stop. I was addicted to meth for 30 years but haven't used since 2003.
PatientReceived no prior treatments
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